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At Tundra Testing, precision is our mission, and as a Laboratory Manager, you'll lead the charge in ensuring every sample meets the highest standards of accuracy and reliability. You'll be at the helm of our operations, guiding a team of skilled technicians in an environment where precision and accountability are second nature. Your expertise in running efficient and compliant laboratories will align our processes with rigorous ISO/IEC 17025:2017 standards. We're seeking someone who thrives on leadership and process improvement, ready to manage resources and streamline workflows to deliver analytical data that drives smarter decisions.

At Tundra Testing, we foster a culture of discipline, accountability, and service, combining cutting-edge technology with our expertise to support vital industries. Here, professional growth is encouraged, and your impact is significant and valued. If you're ready to take on a role that empowers you to make a difference, let's make strides together in our mission-driven laboratory. Join us in our commitment to precision, respect, and unwavering integrity.

$115,000 yearly

• Lead and mentor a team of laboratory technicians, fostering a culture of precision and accountability.
• Oversee daily laboratory operations, ensuring compliance with ISO/IEC 17025:2017 standards.
• Develop and implement efficient workflows to optimize laboratory processes and resource management.
• Ensure the accuracy and reliability of all test results, maintaining the highest standards of quality.
• Collaborate with cross-functional teams to drive continuous improvement and innovation in laboratory practices.
• Manage laboratory budgets and resources, ensuring cost-effective operations without compromising quality.
• Conduct regular audits and inspections to ensure compliance with safety and regulatory requirements, protecting both staff and community health.

• Education: Bachelor’s degree in Chemistry, Environmental Science, Biology, or related field (advanced degree preferred).
• Experience: Minimum 5 years in laboratory management or supervisory leadership within an environmental, analytical, or materials testing lab.
• Strong working knowledge of ISO/IEC 17025:2017, QA/QC systems, and analytical method traceability.
• Excellent leadership skills with a focus on mentorship, accountability, and high-performance culture.
• Proficiency in laboratory safety management, including OSHA, NIOSH, and Alaska DEC standards.
• Experience with LIMS platforms, data integrity, and audit documentation.
• Exceptional communication and problem-solving skills, with the ability to balance technical detail and operational oversight.

At Tundra Testing, precision isn’t just a promise — it’s our mission. We’re a Veteran-led, Alaska-owned environmental and materials testing laboratory based in Anchorage, strategically located near Ted Stevens International Airport to shorten the distance between sample and solution.

Our team delivers defensible, compliance-ready data for soil, water, air, and biological materials using EPA-approved, ISO/ASTM/NIOSH-validated methods. We support Alaska’s most vital industries — oil and gas, construction, real estate, and environmental development — with a focus on speed, transparency, and regulatory confidence.

Driven by a culture of discipline, accountability, and service, we combine cutting-edge technology with local expertise to produce results that meet or exceed federal and state standards. Every analysis, every report, and every client relationship reflects what we stand for: respect, precision, and unwavering integrity.

Compensation details: 115 Yearly Salary

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Company Overview

GTI designs, engineers, and manufactures complex modular systems supporting energy storage, power generation, modular data center infrastructure, defense, and industrial markets. Operating in a high-mix, engineered-to-order manufacturing environment, GTI delivers steel enclosures, integrated platforms, and mission-critical modular systems. Maintaining safe operations, environmental compliance, and disciplined quality systems is critical to GTI’s manufacturing performance and ISO 9001-certified operating environment.

Position Overview

GTI is seeking a Director of Environmental Health & Safety (EHS) to lead enterprise safety, environmental compliance, and risk management across manufacturing operations. This role is responsible for developing and enforcing EHS programs that protect employees, ensure regulatory compliance, and support operational excellence in fabrication-driven manufacturing environments. The Director of EHS partners closely with Operations, Engineering, Quality, and Supply Chain leadership to embed safety into daily production activities while maintaining compliance with OSHA regulations, environmental standards, and ISO-aligned quality systems.

Key Responsibilities

• Develop and lead GTI’s Environmental Health & Safety strategy across manufacturing facilities

• Establish and enforce safety programs aligned with OSHA, EPA, and applicable state and federal regulations

• Build and maintain safety management systems that support ISO 9001 operational discipline

• Lead site-level safety initiatives including hazard identification, risk mitigation, and safety audits

• Oversee incident investigations, root cause analysis, and corrective action implementation

• Develop leading and lagging safety KPIs including TRIR, DART, near-miss reporting, and incident frequency rates

• Implement safety training programs covering equipment operation, lockout/tagout, confined space, welding safety, and industrial hazards

• Partner with manufacturing leadership to integrate safety into fabrication, assembly, welding, and production workflows

• Ensure environmental compliance including waste handling, hazardous material storage, emissions reporting, and regulatory documentation

• Manage site emergency response planning and incident preparedness

• Conduct internal audits and inspections to verify compliance with safety and environmental standards

• Develop and maintain safety documentation, policies, and regulatory reporting requirements

• Lead continuous improvement initiatives to reduce workplace hazards and improve operational safety culture

• Collaborate with HR and Operations to support worker safety training, onboarding safety orientation, and compliance programs

• Provide executive reporting on safety performance, compliance risks, and improvement initiatives

Required Qualifications

• Bachelor’s degree in Environmental Health & Safety, Occupational Safety, Industrial Engineering, Environmental Science, or related field

• 10+ years of EHS experience within industrial manufacturing or fabrication environments

• 5+ years of leadership experience managing EHS programs or safety teams

• Strong working knowledge of OSHA regulations and environmental compliance standards

• Experience implementing safety systems within ISO-aligned manufacturing environments

• Proven experience leading incident investigations and corrective action programs

• Strong knowledge of industrial hazards including welding, fabrication, heavy equipment, and manufacturing processes

• Demonstrated ability to influence plant leadership and drive safety culture improvements

Preferred Qualifications

• Certified Safety Professional (CSP), Certified Industrial Hygienist (CIH), or similar certification

• Experience in fabrication, modular manufacturing, or heavy industrial environments

• Experience supporting multi-site manufacturing operations

• Familiarity with environmental reporting, hazardous materials management, and sustainability initiatives

• Experience building enterprise EHS programs in growth-stage manufacturing organizations

Cosmetic Compliance Consultant- Dental Whitening Products

Key Responsibilities:

1. Develop and lead global regulatory strategies for cosmetic and borderline products, ensuring alignment with FDA, EU MDR, and other international requirements.

2. Conduct comprehensive gap assessments against cosmetic, OTC, and product safety regulations; determine required technical documentation and assess existing files for deficiencies.

3. Prepare, review, and submit regulatory documentation, including PIFs, CPSRs, 510(k) submissions, PMAs, Technical Files, and Design Dossiers.

4. Create and manage remediation plans to close gaps in product documentation, regulatory submissions, and internal processes.

5. Evaluate regulatory impact of product, supplier, or process changes, conduct gap analyses, and coordinate necessary notifications or filings.

6. Lead audit readiness efforts, representing the organization during FDA inspections, Notified Body audits, and responding to CAPAs with robust documentation.

7. Review and approve labeling, IFUs, promotional materials, and packaging in accordance with 21 CFR Part 801, EU MDR Annex I, and cosmetic regulations.

8. Manage UDI compliance, EUDAMED submissions, PMS, vigilance reporting, and adverse event investigations per ISO 13485 and ISO 14971.

9. Act as primary liaison with FDA, Notified Bodies, and regulatory authorities; provide mentorship on regulatory intelligence and best practices.

Competency:

1. Proficient in MS Office, Excel Macros/VBA, PLM tools (e.g., Windchill), QMS platforms, and RegTech systems (MasterControl, RIMS); strong skills in Excel/SQL for data analysis and tracking.

2. Deep expertise in FDA, EU MDR/IVDR, ISO 13485, ISO 14971, regulatory intelligence, and risk management

3. Strong analytical aptitude, exceptional attention to detail, excellent stakeholder management, and advanced technical writing skills

Education/Experience:

1. Bachelor’s degree in Engineering, Regulatory Affairs, Biomedical Engineering, Life Sciences, Pharmacy, or related discipline (RAC certification preferred).

2. 8+ years of experience in cosmetic compliance with hands-on experience in dental/whitening products, borderline classifications, OTC/GPSR, safety reports, PIFs, safety assessments, and international regulatory requirements.

3. Proven ability to collaborate as a regulatory SME, delivering practical, customized compliance solutions.

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

JobOverview

The Staff Engineer, Sustainabilityleads sustainability initiatives across product development, operations, and supply chain whileestablishinggovernance frameworks. It ensures measurable environmental impact reductions, compliance with FDA/ISO standards, and trusted performance metrics aligned with business strategy.

Job Responsibilities and Essential Duties

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  Drive carbon reduction roadmap and eco-design principles.

  
  
  

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  Lead lifecycle assessments and integrate sustainability into product development.

  
  
  

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  Collaborate with suppliers on low-carbon initiatives.

  
  
  

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  Support compliance with ISO 14001, ISO 14040, and FDA standards.

  
  
  

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  Ensure raw material complianceto include RoHS, REACH, EU MDR Prop65

  
  
  

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  Define and standardizegovernance & KPI'sacross teams.

  
  
  

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  Ensure data integrity and consistent reporting.

  
  
  

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  Build dashboards to track sustainability and performance KPIs.

  
  
  

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  Review and updategovernanceto align with evolving strategies.

  
  
  

MinimumRequirements

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  Degree in Engineering, Sustainability,Project Management,or Data&Analytics.

  
  
  

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  7+years in sustainability, governance, or regulated environments.

  
  
  

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  Knowledge of lifecycle assessment, ISO frameworks, and BI tools (Power BI, Tableau).

  
  
  

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  Strong communication, stakeholder management, and analytical skills.

  
  
  

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  PMP Certification a plus.

  
  
  

Salary range: $98,000.00 - $125,000.00 plus bonus targeted at 10% (depending on overall company performance)

#LI-LG1

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

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• Health, Dental, and Vision insurance benefits
  
• 401k plan with company match
  
• Paid Time Off
  
• Wellness initiative & Health Assistance Resources
  
• Life Insurance
  
• Short and Long Term Disability Benefits
  
• Health and Dependent Care Flexible Spending Accounts
  
• Commuter Benefits
  
• Parental and Caregiver Leave
  
• Tuition Reimbursement
  

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Avantor | NuSil is looking for a Quality Control Supervisor to join our team supporting manufacturing of high-purity silicone products. In this role you will provide leadership, technical, and strategic guidance, supporting quality operations for chemical manufacturing in an ISO 9001 and AS9100 certified environment.You will also drive and engage with continuous improvement activities to support the QC lab and overall business objectives.

This role will be a full-time, 2nd shift: 3:00pm - 11:30pm, onsite position based out of our Carpinteria, CA facility.If you are a transformative leader seeking an exciting opportunity to drive quality initiatives - let's talk!

What we're looking for

• Education: High School completion or equivalent (GED) is required; Bachelor's degree in Biology, Biochemistry, Chemistry or science related field is highly preferred
• Experience: 3 years of related/applicable lab or manufacturing experience is highly preferred
  • A proven leader, in a manufacturing and QC lab environment, that can contribute to maturing Quality functions, systems and risk-based processes to achieve business objectives
  • A quality, compliance, and business minded individual that values a growth mindset, partnerships, and collaboration
  • Excellent communication, interpersonal and people management skills
  • Demonstrated knowledge on the application of regulated quality and production risk-based processes
  • Strong analytical and problem-solving skills
• Collaboration Tool: Familiarity with MS Office (Word, Excel, Access)
• Preferred Qualifications:
  • Minimum 1 year of supervisory experience and/or leading a team
  • Preferred experience in quality systems, quality assurance, and quality control
  • Experience with a regulated ISO 9001 and/or AS9100 manufacturing environment

How you will thrive and create an impact

• Directly supervises the quality control staff, monitor individual skills and abilities for most efficient operation; follow progress of work; anticipates or investigates delays of inadequate performance; take corrective action within limits of established practice; aid other departments as needed.
• Provides on the floor and technical support to quality control associates
• Support and enforce the quality system, regulatory policies and work instructions.
• Maintain quality and quantity of output; arrange for equipment, materials and supplies to be available for work assignments; see that equipment is given proper care; troubleshoot faulty operations to determine cause and arrange for required repair and maintenance.
• Provide or arrange for training and cross-training to employees in the performance of duties; assist and instruct personnel as necessary to insure proper flow of work through department.
• Provide guidance to all level Technicians including test methods, analytical technique, good laboratory practice, paperwork completion, equipment, schedule interpretation, and LIMS support.
• Review and approval of controlled Quality Control documents including but not limited to: specifications, procedures, work instructions, validation protocols and validation reports.
• Ensure department documents and procedures are up to date and reflect current practice; revising procedures & processes when needed.
• Performs investigations for laboratory out of specification results, safety related incidents and/or processes related to the QC laboratory.
• Work with customers, regulatory agents and vendors during audits and site visits.
• Understands regulatory requirements for 21 CFR820, ISO 17025, EXCiPACT, GLP, GMP including USP/EP general practices and procedures.
• Proactively maintains current industry and regulatory knowledge for medical devices, ISO 17025, GMP principles and current analytical technology.
• Assist in determining priority of urgent items and appropriate action plan to effectuate priority.
• Approve rejections and rework actions as recommended by Quality Control Technicians.
• Enforce prescribed safety rules and regulations; insure that work areas are maintained in a neat and orderly condition; perform safety and security procedures to open and close buildings and facilities.
• Performs other duties as assigned.

KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

• Strong interpersonal and organizational skills
• Ability to work in a team environment
• Ability to identify and resolve issues
• Strong decision making skills
• Ability to lead a team and provide guidance
• Strong attention to detail
• Strong communication skills

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

Typically works in a lab environment with adequate lighting and ventilation and a normal range of temperature and noise level. At times, may be exposed to a variety of different chemicals including flammables, corrosives, oxidizers and others.

Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.

A frequent volume of work and deadlines impose strain on routine basis.

Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.

#LI-Onsite

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.

The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.

We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

The expected pre-tax pay for this position is

Actual pay may differ depending on relevant factors such as prior experience and geographic location.

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

3rd Party Non-Solicitation Policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Build a Career That Matters with One of the World's Most Respected Employers!

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Operates independently and cooperates with other Central Metrology Technicians to guarantee precision, dependability, and adherence to established standards for calibrations within Central Metrology Lab Scope.

Calibration: Check, analyze, and recalibrate measurement devices based on established criteria, maintaining accurate readings.

Documentation: Maintain clear, detailed logs of laboratory standards, calibration procedures, test findings, and maintenance carried out to follow quality management systems and external guidelines (e.g., ISO 17025).

Process improvement: Partner with fellow Central Metrology Technicians and Internal Business Partners to advance metrology practices and calibration protocols, spot opportunities for progress, and carry out solutions.

Training: Provide training and guidance as needed to other technicians and internal business partners on metrology and calibration techniques and standard methodologies.

Troubleshooting: Detect and address inconsistencies in process and procedures by conducting root cause analysis.

Works autonomously and collaboratively with other Central Metrology Technicians to ensure precision, reliability, and conformity to defined standards for calibrations within the Central Metrology Lab Scope.

Calibration: Assess, test, and calibrate measurement devices following established standards, maintaining accurate readings.

Documentation: Carefully and thoroughly record all laboratory standards, calibration processes, test outcomes, and maintenance to meet quality management systems and external criteria (e.g., ISO 17025).

Process improvement: Work alongside other Central Metrology Technicians and Internal Business Partners to advance metrology techniques and calibration procedures, detect areas needing improvement, and apply solutions.

Training: Deliver instruction and mentorship as required to other technicians and internal business partners regarding metrology and calibration techniques and standard processes.

Troubleshooting: Detect and address inconsistencies in processes and procedures by conducting root cause analysis.

Adhere to safety protocols and procedures, including the use of personal protective equipment (PPE).

Perform calibrations on a wide range of measuring devices using precision measuring instruments and software, ensuring environmental controls in the lab are adequate before performing calibrations. Detect and communicate any measurement/calibration nonconformities to all interested parties.

Record and document test results, maintenance performed, and any deviations or non-conformities in calibration logs, records, and certificates, ensuring traceability and adherence to quality and regulatory standards.

Coordinate and arrange the servicing of devices alongside other Central Metrology Technicians to enhance lab operational efficiency. Use organizational and time management abilities to handle workloads and schedules efficiently.

Assist in the development and/or update of calibration procedures and documentation in accordance with National, International, or Industry Standards.

Provide technical aid and advice to colleagues and Internal Business Partners.

> Perform calibration of various parameters of gauge types, as approved by procedure training, evidence of competency, and maintaining individual uncertainties in alignment with other calibration technicians

• Dimensional - Hand tools, Hard gauges, Surface Plate Flatness etc.
• Mechanical- Pressure, Vacuum, and Torque
• Electrical - Multimeters, Thermocouples and RTD's
• Chemical - Refractometers, pH Meters, and Conductivity meters etc.
• Sound level meters, Belt tensioners etc.
• Vision Systems
• Coordinate-measuring machine (CMM)

> Strong knowledge of measurement science (metrology)

• Understand contributors and variables that influence the development of an uncertainty budget.

> Ability to read and interpret technical manuals, blueprints, schematics and diagrams

Engage in Intra-laboratory and external laboratory Proficiency tests as needed. Not passing Proficiency tests may lead to corrective or preventative measures, including remedial training and/or restriction from calibrating certain types of gauges.

Attention to detail: Meticulous and precise, with a focus on accuracy.

Problem-solving: Strong analytical skills for troubleshooting and resolving complex issues

Computer skills: Proficiency with calibration software and other computer-based test equipment

Communication: Ability to clearly communicate technical information and work effectively in a team. Collaborate with Plants regarding processes, procedures, and corrective/preventative actions, when gauges are found to be out of tolerance.

Understanding of standards: Experience with quality and regulatory standards (e.g., ISO 17025, ISO 9001)

Associate degree or Certificate from a technical school or military training

ASQ Certified Calibration Technician Certification is a plus.

Ready to Shape the Future of Innovation?

Michelin is building a world-leading manufacturer of life-changing composites and experiences. Pioneering engineered materials for more than 130 years, Michelin is uniquely positioned to make decisive contributions to human progress and a more sustainable world. Drawing on its deep know-how in polymer composite materials, Michelin is constantly innovating to manufacture high-quality tires and components for critical applications in demanding fields as varied as mobility, construction, aeronautics, low-carbon energies and healthcare.

The care placed in its products and deep customer knowledge inspire Michelin to offer the finest experiences. This spans from providing data- and AI-based connected solutions for professional fleets to recommending outstanding restaurants and hotels curated by the MICHELIN Guide.

Why Michelin?

• Career Growth: Personalized development plans, mentorship, and cross-functional opportunities. Unique career paths and opportunities for advancement.

• Inclusive Culture: Thrive in a diverse, supportive environment where your competencies, contributions and behaviors are recognized. Option to join one of our Connected Communities.

• Innovation-Driven: Work on projects that matter-from sustainable materials to digital transformation.

• Community Impact: Be part of a company that does what's right. We use sustainable business practices while balancing the needs of our customers and communities.

Michelin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors. Consistent with these obligations, Michelin also provides reasonable accommodations to employees and applicants with disabilities and for sincerely held religious beliefs. If you need accommodation for any part of the employment process because of a disability, please contact us at .

This position is not available for immigration sponsorship.

We build the future with people like you. Begin your career with Michelin today!

Lou-Rich is seeking a skilled and detail-oriented Assembler to join our team. As an Assembler, you will play a crucial role in our manufacturing process by accurately and efficiently assembling components to create finished products. You will be responsible for ensuring that the highest quality standards are met and that all products are assembled according to specifications. Your precision and attention to detail will contribute to the overall success and customer satisfaction of our organization.

About Innovance, Inc.

Innovance is the holding company for a family of four, 100% employee-owned, Minnesota-based manufacturing companies (Lou-Rich, ALMCO, Panels Plus, Mass Finishing). Our mission is to lead, nurture, and grow a team of industrial manufacturing companies committed to making our OEM customers products better.

About Lou-Rich

Lou-Rich is a fully integrated contract manufacturer specializing in complex projects. We provide precision machining, metal fabrication, assembly, and sourcing solutions to a variety of industries, including some of North Americas largest OEMs. Companies of all sizes from Fortune 500 companies to small, fast-growing operations trust Lou-Rich with their most vital and complex manufacturing projects.

Position Description:

Perform sub assembly and final assembly processes on a variety of mechanical and electrical assemblies. Will use calibrated equipment and machinery, engineering and simple drawings, schematics, as well as written and verbal instructions to perform basic assembly, mechanical, and electrical functions. Will also maintain documentation on work performed, match work procedures with ISO documents, and read and interpret sketches and/or blueprints to describe or identify non-conformance.

Essential Functions:

Utilize hand tools, power tools and hardware to assemble and wire standard and engineered products to customer specifications and quality standards with the aid of supervision or trainers.

Apply acquired trade skills such as electrical, mechanical and plumbing to complete assembly process.

Follow ISO procedures.

Perform job set-up by obtaining necessary/required parts, drawings, and schematics. Check for correctness of parts by referencing the bill of material. Read and interpret drawings and schematics.

Communicate with engineers, designers, and technicians to resolve assembly discrepancies.

Perform ongoing inspection of product during assembly and wiring process and prior to products shipment.

Lift and position assemblies. Operate overhead hoist/crane to assist with the lifting and control of moving/positioning of assembly.

Maintain a clean, safe, and orderly work area.

Set-up and performs Assembly Department operations with minimum supervision.

Familiar with mechanical and electromechanical components.

Thorough understanding of part prints (tolerances, symbols, etc.).

Perform checks for quality of parts and make adjustments as required.

Perform other duties as assigned.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

High School Diploma or equivalent

Entry level or 1-2 years of assembly experience

Knowledge of ISO

Familiar with mechanical and electromechanical components

Able to read and interpret routings, bills of material, assembly drawings, work instructions and notes

Manual dexterity

Ability to work in a team setting

A positive can-do attitude

Strong motivation and communication skills

Problem solving skills

Refuse to be satisfied with average performance

Other duties as assigned

Lou-Rich Training Requirements:

Applicable training will be completed by following the syllabi (Human Resources, Safety, IFS Time clock, IFS - Navigation, ISO, Inspection Hand Tools, Inspection Forms, CMM, and Technical) for each new hire and that will be verified by the Employee Orientation & Job Qualification form within the first 60 days of employment. Additional applicable training will be completed by following the individuals assigned department training matrix, Paint Line (F4400-355).

Follow training syllabus (Technical from above list). Effectiveness of training guidelines will be determined by employee knowledge and demonstration of learned concepts. Additional training after the first several weeks of on-the-job training will be determined by the Supervisor in preparation to operate on their own as needed. Any follow-up training will be evaluated and provided at the 60-day review or as deemed necessary for the position.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands and fingers, and talk and hear.

Work Environment:

The work environment characteristics described here are representative of those and employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Americans with Disabilities Act:

If you are a qualified individual with a disability, you have a right to request that the Authority make reasonable accommodations in order to help you accomplish your work, which must still be performed in all essential functions.

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Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.

MCRA's client, a commercial-stage medical device company specializing in designing, developing, and marketing orthopedic fracture repair and stabilization products, is in search of a Director of Quality and Regulatory Affairs to provide support across Regulatory, Quality Assurance, Operations, and Research & Development (R&D).

Primary Roles:

• Is a key member of the senior leadership, and is responsible for the successful operation of the company's quality and regulatory systems. Essential functions include the development, implementation, maintenance, and improvement of company-wide quality and regulatory systems, integrating continuous improvement activities.
• Serves as our clients Management Representative under ISO and FDA requirements, and takes the lead role in ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of applicable regulatory agencies. Responsible for the generation and maintenance of our client's Quality systems, with direct oversight for the processes for Complaints Management, CAPA, Risk Management, Post-Market Surveillance, and Regulatory Reporting.
• Is responsible for leading the resolution of quality and compliance issues within the business and provide routine quality feedback and leadership to cross-functional groups
• Serves as the official correspondent to Competent Authorities (e.g. FDA, EU countries, etc) as well as Notified Body. Responsible for maintaining compliance registrations and device listings.
• Ensuring compliance with FDA and other applicable international regulations and requirements for the design, development, distribution, and maintenance of medical devices and provide general regulatory support to the organization

Responsibilities:

Quality Systems

• Provide operational leadership in planning and management of quality system activities to maintain appropriate QMS certification
• Responsible for leading and interfacing with any Notified Bodies or Competent Authorities during inquiries or facility inspections by such organizations
• Acts as lead in all product complaint and recall campaigns.
• Responsible for interfacing with and following up with any Customers regarding complaints
• Responsible for Supplier Quality assurance program
• Responsible for Measurement, analysis and improvement programs, including quality trending, CAPA system, and the Internal Quality Audit program for our client.
• Leads the Management Review process

Quality Engineering

• Ensures all inspection and quality plans are statistically sound and can ensure quality levels that exceed requirements
• Ensures all device history records are complete and reviewed prior to release of product
• Assist suppliers by providing information to enable process improvements
• Ensure all manufactured products are conforming to FDA Quality System, ISO 13485, MDD, and MDR
• Supports the engineering staff with PPQA activities, validations, and statistical analysis of new products and processes
• Leads Risk Management and Post-Market Surveillance activities

Regulatory Affairs

• Develop and implement global regulatory and compliance strategies to:
• Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy;
• Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirement
• Optimize and focus on quality during the design and change control processes for both new and existing products;
• Ensure all advertising and promotion materials conform to applicable FDA, EU, and, where applicable, other country regulations.
• Responsible for the CE Mark approval process for all products, and Technical File generation and maintenance
• Responsible for writing Letters to File as required
• Participates in the development and writing of 510(k) submissions with the management team utilizing external resources as required
• Responsible for external agency reporting

Education:

• Bachelor’s Degree in Engineering or Natural Science preferred, coupled with approximately 10 years of combined experience in QA / RA in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the MDD and MDR Directives, as well as ISO 13485 requirements. 5 years of experience managing supervisory personnel and contributing toward the development of department strategies.

Experience/ Skills:

• Ability to build efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metrics
• Demonstrated ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, trend report
• Has experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.
• Demonstrated leadership skills and team building skills, inspires others toward continuous quality improvement
• Able to solve complex quality, technical, managerial or budgeting problems
• Readily adapts to changing priorities, effectively manages own time and direct reports to ensure tasks, projects are completed on time to meet growth objectives. Adjusts easily and readily to a fast-paced work environment
• Working knowledge of data acquisition, analysis and statistical software
• Demonstrated ability to manage multiple projects and technical personnel simultaneously
• Successful oral and written communication skills, business acumen and assertive decision-making ability
• Excellent computer skills, including MS Office proficiency

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Food Safety Quality Assurance Manager

• Bachelor's degree in Science
• Food and beverage industry
• Certifications: SQF Practitioner Certificate, HACCP and PCQI
• In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles.
• Strong experience in QA/QC processes including conducting quality audits.
• Oversee daily, weekly, and deep-cleaning operations, ensuring equipment is properly sanitized and ready for production.

Are you looking to make a career change to a rapidly growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you

Very Competitive Benefits Package

Excellent Growth and advancement opportunities

Employment Type:

Full-time

Job Requirements and Duties:

• Bachelor's degree in Science
• 5 plus years of food manufacturing industry experience
• Certifications: SQF Practitioner Certificate, HACCP and PCQI
• Preventive Controls Qualified Individual (PCQI) in accordance the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food Rule
• In-depth knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP principles.
• Strong experience in QA/QC processes including conducting quality audits.
• Manage the Food Fraud Program and Plant Security/Vulnerability Programs
• Assist in New Customer Setups by verifying internal documentation matches customer specification requirements
• Write, maintain, and improve quality system SOPs
• Provide oversight and leadership of facility Quality Assurance team. Responsible for hiring and team member development
• Manage the day to day operation of all quality function
• Lead the team in the execution of HACCP plans and ensure proper documentation is maintained
• Ensuring that manufacturing processes comply with standards at both National/ International level
• Review SOPs & specifications
• Oversee all aspects of daily quality operations
• Manage budgeting
• Ensure compliance with Federal, State and Local food safety regulations
• Understanding of industry standards of Food Safety and Quality
• Supports and participate to all the internal/external audits
• Review test results
• Provide, and oversee, inspection activity for product throughout production cycle
• Apply total quality management tools and approaches to analytical and reporting processes
• Schedule and coordinate preparations for product inspections and testing
• Work to resolve noncompliance issues with materials or final product
• Exceptional interpersonal skills and organizational skills

Benefits:

• Great Pay
• Very Competitive Benefits Package
• Excellent work environment with growth opportunities
• Immediate Hire

Jasleen Kaur

Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.

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Job Title: Manufacturing Engineer

Department: Coating Services

Status: Full Time - Exempt

Reporting To: Director of Operations / X40 Production Manager

Position Purpose:

We are seeking a proactive and technically skilled Manufacturing Engineer to support and improve manufacturing processes applied to customer-supplied medical devices. This individual will be responsible for process improvement, leading root cause investigations, working closely with cleanroom operators across shifts, and serving as a key technical liaison with both internal teams and external customers. This role requires up to 25% international travel to support HMS production sites, audits, process transfers, and troubleshooting.

Responsibilities:

Production Support & Engagement

• Build strong relationships with production staff and foster a culture of collaboration and continuous improvement
• Monitor and adjust key process variables to ensure product consistency and high-quality output
• Assist with new process transfers from Method Development to Production

Process Improvement

• Continuously improve coating processes (e.g., dip, plasma)
• Apply Lean principles to manufacturing processes (eliminate waste in the manufacturing process and apply innovative systems to improve company workflows)
• Maintain and revise technical documentation including SOPs, work instructions, and validation of PQ protocols
• Perform internal audits on manufacturing lines
• Analyzing production data to identify areas for improvement in efficiency, cost, and quality.

Root Cause Analysis & Technical Problem-Solving

• Lead structured, cross-functional, root cause investigations for coating-related defects or process deviations using methodologies such as 5 Whys, Fishbone Diagrams, and DMAIC
• Act as the technical lead during customer escalations, investigations, and audits related to coating performance or compliance related to manufacturing
• Drive the implementation of corrective and preventive actions (CAPAs) and ensure timely documentation and communication of findings

Compliance & Documentation

• Ensure manufacturing processes comply with ISO 13485 and internal QMS requirements
• Support and lead validation activities for new and modified processes
• Maintain accurate and compliant documentation to support audits and regulatory inspections
• Implementing and monitoring quality control procedures to ensure products meet customer spec.

Support and/or perform other duties as required

Education, Qualifications & Experience:

• Bachelor’s degree in Engineering (Mechanical, Industrial, Manufacturing) or a related field
• 5+ years of experience in manufacturing engineering, industrial engineering, or process engineering role, preferably in a regulated medical device or pharmaceutical environment
• Lean / Six Sigma Green Belt or higher preferred.
• Demonstrated expertise in leading root cause investigations and communicating findings directly to customers
• Experience working in or supporting cleanroom operations and collaborating with production operators
• Knowledge of coating processes and surface treatments for medical devices is strongly preferred
• Familiarity with process validation, GMP, and ISO 13485
• Excellent interpersonal and communication skills – comfortable interfacing with both customers and shop floor teams.
• Proficiency in CAD/CAM software (or similar): Ability to use computer-aided design and manufacturing software for design and simulation.

Working Conditions and Health & Safety:

• Heated and air-conditioned office environment
• ISO Class 7 Cleanroom
• Laboratory
• Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing space.

Harland Medical System’s commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System’s internal procedures, where deemed appropriate per assigned job functions.

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit for prolonged period of time. The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist. Using proper lifting techniques, the employee must be able to lift up to 40 lbs.

Quality Control Roving Inspector

Location: West Chester, Pennsylvania

Industry: Precision Medical Device Manufacturing

Job Type: Full Time | 100% Onsite

Shifts: 1st (7:00am–3:30pm), 2nd (3:00pm–11:30pm)

Relocation: Available case by case

Position Overview

Performs in-process and final inspections across multiple machining cells. Acts as a floor-level quality resource supporting machinists and inspectors to maintain quality standards within a regulated medical device environment.

Core Responsibilities

• Perform in-process and final inspections across machining cells
• Support machinists and production teams with quality questions
• Inspect parts using calipers, micrometers, comparators, and other precision tools
• Identify and document nonconformances
• Support corrective actions and quality improvements
• Ensure compliance with ISO 9001 and ISO 13485 standards

Must-Have Qualifications

• 5+ years quality experience in precision machining environment
• Strong blueprint reading and GD&T knowledge
• Experience performing in-process and final inspections
• Proficiency using calipers, micrometers, and comparators
• Working knowledge of ISO 9001 and ISO 13485 standards
• Strong communication and problem-solving skills

Preferred Qualifications

• CNC or Swiss machining background
• Experience generating NCRs and supporting corrective actions
• Experience mentoring inspectors or production staff
• Quality certifications such as CQT, CQI, or Six Sigma

Work Environment & Process

• Precision, climate-controlled medical device facility
• Regulated and quality-driven environment
• Uniforms and safety equipment provided at no cost
• Overtime based on production demands
• Interview process includes virtual interviews, onsite visit, and skills assessment

Job Title: Quality Assurance & Compliance Manager (Aerospace / Precision Machining)

Department: Quality

Reports To: General Manager / Director of Operations

Location: Southampton, MA

FLSA Status: Exempt

Position Summary

Responsible for leading the Quality Management System (QMS) and ensuring compliance with aerospace, defense, and customer requirements. Oversees ISO 9001 / AS9100 certifications, audits, inspection processes, documentation, and traceability within a precision machining or aerospace manufacturing environment.

Key Responsibilities

• QMS & Continuous Improvement
• Manage and improve the QMS in compliance with ISO 9001 and AS9100.
• Maintain procedures, work instructions, and document control.
• Lead CAPA, root cause analysis, and continuous improvement initiatives.
• Track and report quality performance metrics.

Certification & Compliance

• Maintain ISO 9001 / AS9100 certifications and audit readiness.
• Coordinate third-party and customer audits.
• Ensure compliance with customer flow-downs and contract requirements.
• Monitor and implement regulatory/standards updates.
• Aerospace & Defense Quality
• Ensure compliance with AS9102 FAIRs, traceability, and special process controls.
• Support ITAR/EAR and DFARS requirements as applicable.
• Maintain material, process, and certification records.
• Coordinate with NADCAP-approved suppliers.

Inspection & Production Support

• Oversee inspections to drawings, GD&T, and specifications.
• Manage calibration of inspection equipment.
• Control travelers/routers and in-process/final inspection records.
• Support production in resolving nonconformances.

Audits & Supplier Quality

• Conduct internal audits and manage corrective actions.
• Support supplier qualification, monitoring, and audits.
• Ensure timely closure of audit findings.

Customer Quality

• Interface with customers on quality issues and audits.
• Manage portal submissions and reporting.
• Oversee FAIRs, PPAPs, and required documentation.

Training & Leadership

Train staff on quality and compliance procedures.

Promote a culture of quality and traceability.

Advise production, engineering, and purchasing on requirements.

Qualifications

Required

• Bachelor’s degree in Quality, Engineering, Manufacturing, or related field (or equivalent experience).
• 5+ years in aerospace, defense, or precision machining quality.
• Experience with ISO 9001 / AS9100 systems.
• Proficiency in GD&T, blueprint reading, audits, and root cause analysis.

Preferred

• CQE, CQA, or ASQ certification.
• CNC machining / precision manufacturing experience.
• ERP / QMS system familiarity (Epicor a plus).
• Experience with aerospace primes or Tier suppliers.

Skills & Competencies

• Analytical problem-solving.
• Strong documentation and organization.
• Effective auditor/customer communication.
• Detail-oriented with regulatory focus.
• Ability to manage multiple priorities.

Work Environment & Metrics

• Office and shop-floor presence.
• Interaction with production, suppliers, and customers.
• Occasional audit/customer travel.

Success Measured By:

• Certification maintenance.
• Audit results and corrective action closure.
• Reduced nonconformances.
• On-time FAIRs and documentation.
• Supplier and customer quality performance.

Job Title: Product Owner – Embedded System Development

Location: Portland, OR

Job Type: Full-Time

Job Overview

We are seeking an experienced Product Owner – Embedded Systems Development to drive product vision, roadmap, and delivery for embedded platforms, including Android, Linux/QNX, and kernel-level infrastructure environments. The role requires close collaboration with automation, infrastructure, and development teams to ensure effective backlog management, strategic alignment, and predictable sprint delivery.

The ideal candidate will possess strong experience working with embedded or automotive software development teams, with the ability to translate product requirements into clear features, user stories, and acceptance criteria, while ensuring alignment with program objectives and development timelines.

Key Responsibilities

Product Ownership & Backlog Management

• Own and manage the product backlog for embedded software and automation frameworks.
• Define features and user stories with clear Definition of Done (DoD) and acceptance criteria.
• Ensure traceability by linking features and stories to product and system requirements.
• Prioritize backlog items to align with program goals, engineering capacity, and sprint planning.
• Continuously refine and groom backlog items in collaboration with engineering teams to ensure clarity and feasibility.

Agile Delivery & Team Collaboration

• Work closely with Scrum Masters, Engineering Leads, and development teams to drive predictable, iteration-based delivery.
• Coordinate with Automation and Infrastructure teams working on Kernel, QNX, Linux, and Android environments.
• Facilitate backlog grooming, sprint planning, and iteration reviews.
• Ensure alignment between automation, infrastructure, and development teams for effective sprint execution.
• Support automation scrum iterations in coordination with senior automation engineers.

Stakeholder Management

• Serve as the primary liaison between engineering teams and product/program stakeholders.
• Communicate priorities, roadmap updates, and sprint outcomes to cross-functional teams.
• Ensure that development activities align with product strategy and program objectives.

Development Process & Technical Collaboration

• Demonstrate strong understanding of software development lifecycle and embedded development processes.
• Collaborate with development and validation teams to drive effective development process management.
• Work closely with engineering teams to ensure technical feasibility and clarity of requirements.
• Support continuous improvement in development workflows, testing strategies, and automation initiatives.

Required Skills & Qualifications

Education:

Bachelor’s or Master’s degree in Computer Science, Electronics, Embedded Systems, or related field.

Experience:

7+ years of experience in product ownership, product management, or technical program roles, preferably within embedded or automotive software development environments.

Preferred Qualifications

• Experience with embedded platforms such as Linux, QNX, Android, or RTOS-based systems.
• Experience working in automotive infotainment, embedded automation frameworks, or system infrastructure teams.
• Strong understanding of kernel-level development environments and embedded system architecture.
• Experience working with cross-functional teams in global engineering environments.

The TSUBAKI name is synonymous with excellence in quality, dependability and customer service. U.S. Tsubaki is a leading manufacturer and supplier of power transmission and motion control products. As a part of a vast, international network of corporate and industrial resources, Tsubaki offers its customers the finest state-of-the-art products available in the world and we strive to be the “Best Value” supplier in the industry.  

The Customer Support / Quality Lead is responsible for providing customer service support, including quotations, delivery information and technical information. Coincidently ensures consistent, compliant, and accurate execution of quality processes by guiding frontline quality activities, resolving issues, and supporting continuous improvement across operations.

Essential Duties and Responsibilities: The essential duties and responsibilities of this job are included but not limited to this job description – other tasks may be assigned and expected to be performed.

Customer Service Functions

• Handles customer requests including quotes, orders, follow-up and delivery information.   
• Provides customer service support, including providing technical information and explanations to customers.
• Fills orders by transferring orders to fulfillment; communicating expected delivery date; explaining stock-outs. 
• Meets established order entry goals.
• Supports members of the outside sales team in daily activities.
• Accomplishes department and organization goals by accepting ownership for accomplishing new and different requests; explore opportunities to add value to job accomplishments.
• Works well in a team environment to solve customer issues.
• Communicates issues and problems with management in a timely manner.
• Maintains superb attention to details.
• Maintains detailed documentation to support decision and ensure continuity of service.

Quality Assurance Functions

• Ensures the performance of quality assurance functions are conducted in the most efficient manner.
• Looks for opportunities to eliminate non-value-added operations and improve processes.
• Assists with the development of plans and strategies to enhance production.
• Lead efforts toward achieving and maintaining ISO 9001 certification.
• Creates, revises, and controls, Quality manual, SOPs, Work Instructions, Forms, and quality procedures.
• Identifies gaps. Ensures root cause analysis and corrective actions are implemented. 
• Collecting and reporting of KPIs for quality management.
• Coordinates resources required to address quality concerns.
• Ensures documentation meets internal and external requirements (e.g., ISO clauses, regulatory expectations). 
• Prepares for and supports customer/certification/regulatory audits; coordinates responses and follow ups. 
• Preserves and maintains training records; ensures staff are trained on relevant procedures, changes and expectations. 
• Manages controlled records (inspection logs, audit reports, risk files) to ensure traceability and retention.
• Conducts internal audits.
• Serves as a cross-functional advisor.
• Other tasks/functions as assigned. 

• Associate’s degree or equivalent.
• 2-3 years of Customer Service experience, preferably in a manufacturing environment. 
• Knowledge of ISO 9001 requirements preferred.
• Acts positively upon constructive criticism and coaching.
• Work independently and in a group across all levels of the organization.
• Ability to multi-task and prioritize work based on deadlines.
• Handles confidential information discreetly.
• Highly detail oriented.
• Communicates clearly and comfortably with all employees. 
• Conducts self professionally & ethically.
• Remains calm under pressure. 
• Places a high emphasis on excellent customer service. 
• Fosters and supports a teamwork environment. 
• Knowledge of order entry/enterprise systems, preferably QAD and Goldmine.
• Strong computer skills with demonstrated knowledge of Microsoft Office programs: Word, Excel, and Outlook

Learn more about U.S. Tsubaki at:    

U.S. Tsubaki offers a competitive compensation and benefits package, including health benefits effective on date of hire, dental and vision benefits effective on the first of the month following date of hire, Paid Time Off ("PTO"), 10 paid holidays, generous 401(k) match and profit sharing, annual bonus potential, life insurance, short and long-term disability, flexible spending accounts, commuter benefits, education reimbursement, home and auto insurance discounts, and pet insurance. 

The estimated salary range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. 

Applicants must be authorized to work for any employer in the United States. Tsubaki does not sponsor or take over sponsorship of employment visas.

Tsubaki is an Equal Opportunity Employer - Minorities/Females/Veterans/Disability

PM21

Compensation details: 6 Yearly Salary

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