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*Position only available on-site in Irvine, CA*

Job Summary:

We are seeking a highly experienced Clinical Studies Coordinator to lead and execute end-to-end clinical studies supporting FDA submissions (510(k)), pilot and feasibility studies, post-market clinical follow-up, and real-world evidence generation.

This role is hands-on, operational, and strategic. The ideal candidate has deep experience managing medical device and digital health clinical studies, working directly with FDA-facing documentation, IRBs, investigators, CROs, and internal regulatory, engineering, and product teams.

This position plays a critical role in de-risking regulatory submissions, ensuring GCP compliance, and translating clinical evidence into successful regulatory and commercial outcomes.

Key Responsibilities:

• Lead the planning, coordination, and execution of clinical studies, including:
• Pilot/feasibility studies
• IDE-exempt and IDE-supporting studies
• Pivotal and non-pivotal studies for FDA 510(k) submissions
• Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)
• Real-world evidence (RWE) and usability studies
• Develop and manage study timelines, milestones, and deliverables
• Ensure studies are conducted in compliance with GCP,FDA regulations, ISO 14155 and other applicable standards.
• Prepare, review, and maintain clinical documentation for regulatory submissions, including:
• Clinical Study Plans (CSPs)
• Protocols and amendments
• Informed Consent Forms (ICFs)
• Statistical Analysis Plans (SAPs) (in collaboration with biostatistics)
• Clinical Study Reports (CSRs)
• Ensure audit-ready clinical documentation at all times

Other Responsibilities:

• Support subject recruitment and enrollment activities
• Conduct blood draws on study subjects.
• Process blood samples.
• Initiate IV's when the MD is unavailable.
• Supervise the maintenance of laboratory equipment, including calibration records.
• Maintain clinical staff training documentation.
• Perform other duties or special projects as requested.

Minimum Qualifications and Experience:

• 7 – 10 years of related experience or equivalent combination of education and experience.
• Excellent communication skills (both written and oral).
• Knowledge of clinical databases and data management systems
• Ability to be an integral part of an innovative, fast-paced product development team.
• Ability to manage multiple concurrent studies is essential
• LVN with IV training certificate or RN.

Preferred Qualifications:

• Bachelor's degree in Life Sciences, Biostatistics, Health Informatics, Biomedical Engineering
• Experience with clinical studies and interfacing with IRB.
• Clinical research certifications

Physical requirements/Work Environment:

This position primarily works in an office as well as laboratory environment. It requires frequent sitting, standing and walking. Work in a lab involves potential exposure to blood borne pathogens, as well as needles. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings, walking in the facilities, or processing tissue samples, blood, etc. Some local travel is necessary so the ability to operate a motor vehicle and maintain a valid Driver's license is required. Some travel to clinical sites might be required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

About the Role

Genesee Polymers Corporation has management's commitment to be a world-class organization and a culture of excellence with the company's focus on best practices and has created an environment for continuous improvement. Our quality system utilizes ISO 9001:2015 as its quality platform. As the Research and Development Chemist, you will have the autonomy to recommend and establish quality control processes and test methods to ensure that our products meets the quality specifications required by our Customers and by the nature of the product itself.

As a member of our Research and Development team, you will stay abreast of the latest technology in sustainability and R&D management in order reach our Quality goals and objectives. Highly visible to senior leadership, you will strive year over year for continuous improvement in the quality control department. You will chart a course of continued success by educating and training our other quality control technicians on new policies and procedures, while collaborating with staff for understanding, agreement, and compliance to Standard Operating Procedures, Work instructions, and other documented processes pertaining to the R&D department.

Responsibilities

• Record research and development data and post in the ERP system
• Work on R&D projects based on demand from Customers
• Analyze and evaluate reaction process to create a successful R&D batch
• Consult with technical director of sample creation results and communicate proper course of action.
• Maintain good electronic record keeping of steps in development for future reference
• Create and maintain SDS submission and TDS on existing and new products
• Maintain all governmental regulatory compliance including but not limited to Chemical Waste disposal profile and manifest, SARA Title II reporting, REACH, SVHC, Conflict mineral reporting, Prop 65, etc.

Qualifications

• Chemistry degree and three years related experience or training; or equivalent combination of education and experience

Required Skills

• Primary knowledge of Silicone Polymers
• Experience in a laboratory for chemical industry is required
• Ability to work independently and remain self-motivated
• Passionate about taking the company's best practices to a higher level of performance
• Strong analytical and scientific skills
• Computer literate in Windows-based database programs and MS Office products
• Ability to write technical papers and document research and development project
• ERP experience a plus
• Chemical Batch manufacturing experience a plus
• Possess excellent organization skills and the ability to prioritize, meet deadlines and multitask independently
• Ability to think independently, communicate thoroughly, and influence the implementation of the appropriate corrective and preventative actions
• Ability to make independent judgments to manage and facilitate company programs/policies as they relate to the R&D department
• Positively interact and influence front-line supervisors and field personnel to create a standardized work environment
• Leadership skills and a proactive mindset and not reactive
• Project management experience a plus

The Role

Our Consulting group is looking for a Consultant to join our Automotive Consulting team. The ideal candidate will have a strong background project management, with a passion for driving strategic security objectives. and ensure that the project progresses smoothly.

We're looking for Consultants who can deliver within Cognizant's Five Pillars of Consulting: 1) Project Execution, 2) Expertise, 3) Business Development, 4) Practice Development, & 5) People Development. As a consultant, this means creating high-quality client deliverables and taking ownership (with supervision) of producing client content and meeting client expectations; developing an expertise in your functional area, including obtaining certifications; contributing to Client Satisfaction and/or RFPs; supporting leadership and contributing to content development for service offerings; and participating in PeopleCare initiatives and always exhibiting personal leadership. In addition to enabling consulting excellence through the Five Pillars of Consulting, the specific requirements for this position are below.

Job Summary:

We are seeking an experienced Program Manager to lead and oversee the successful delivery of cross-functional programs that align with strategic business objectives. The ideal candidate will be responsible for managing multiple related projects, ensuring coordination, minimizing risk, and driving results across stakeholders, timelines, and budgets.

Key Responsibilities:

• Define program goals, scope, deliverables, and success metrics in alignment with organizational strategy.
• Lead planning and execution of multiple projects under the program umbrella.
• Coordinate cross-functional teams to ensure timely delivery of program outcomes.
• Monitor program performance, timelines, and budget adherence.
• Identify, track, and mitigate program-level risks and issues.
• Provide regular updates to leadership and stakeholders through status reports and review meetings.
• Establish governance processes and reporting mechanisms.
• Ensure alignment between business goals, project delivery, and change management.
• Foster collaboration between product, engineering, operations, and other departments.
• Mentor and guide project managers within the program as needed.

Qualifications

• Bachelor's degree in computer science, Information technology, or related field experience.
• 7+ years of proven experience as a Project Manager, Business Analyst and Product Owner, preferably in the automotive sectors or manufacturing sectors.
• Experience working in/around Contact Centers and their operations
• Knowledge of NICE / CXone contact center solutions
• Proficiency in project management tools. JIRA experience is a plus.
• Minimum of 3-5 years managing complex IT programs, including multi-project coordination and resource allocation.
• Proven ability to develop and implement program strategies, ensuring alignment with business objectives and client needs.
• Strong leadership skills to guide project teams, manage stakeholders, and drive program success.
• Knowledge of security frameworks and best practices, such as NIST, ISO 27001, and financial industry regulations is a plus.
• Project Management Professional (PMP) certification is preferred; CISSP or CSM is a plus.

Seeking a Operations Manager to plan, direct, and coordinate manufacturing processes. Oversees day-to-day activities with Engineering team, Production staffing and performance of manufacturing processes. May also act as backup to the Production Manager in their absence.

Duties:

Committed to ensuring the achievement of continuous improvement within area of expertise, as well as areas of business in order to remain at the forefront of meeting Company objectives, thus proactively satisfying customers.

This position mandates that all required safety classes, trainings, and certifications be completed and maintained within the specific position/department.

Is aware of relevance and importance of their activities and how they contribute to the achievement of the quality objectives.

This position requires an employee to work their regularly scheduled shift; ability to work overtime and weekends.

Must be aware and comply with related ISO/IATF procedures, as applicable.

Process Management

Responsible for all internal and external Heat Treating operations, Plating Lines, Plating Lab, Environmental Control and all Surface Finish processes.

Analyzes and plans workforce utilization, space requirements and workflow, layout, tooling, and installation of new equipment and fixtures.

Confers with planning and Production Control concerning available capacity to ensure efficient production flow.

Troubleshoot and resolve problems effectively as they occur in the manufacturing processes.

Estimates and communicates production times, staffing requirements, and related costs for management decisions.

Notifies and advises stakeholders of production problems or potential concerns.

Conducts 'make/buy' decisions on processing (such as heat treat) based on capabilities, cost, and capacity.

Determine which quantities of which parts will be outsourced to approved suppliers.

Drives regular meetings with outside suppliers to review capacity, quality, and deliveries.

Develops, evaluates, and improves manufacturing methods in area of responsibility (AOR).

Ensure all process-centric projects are completed on time and within budget.

Responsible for researching new technology for AOR directly and through Supervisors and Engineers.

Leadership

Drives a culture of continuous improvement for safety, quality, productivity, and work environment.

Leads and attends meetings for assigned projects.

Communicates major and/or complex situations and actions, internally and externally.

Documents and reports on more complex or unique issues and effectively articulates actions and conclusions.

Coaches and mentors and indirect reports.

Provide professional development goals for direct reports.

Establish expectations and clear direction to meet goals and objectives.

Conduct thorough employee evaluations. Ensure goals are reviewed with direct reports regularly.

Develops and maintains professional working relationships in complex and/or difficult situations.

Responsible for ensuring the knowledge in each department within AOR is properly documented and organized.

Ensure operations in AOR meet/exceed the town, county, state, and national requirements.

Travel may be required to support projects, manage customer issues, provide support for sales, gain product information, resolve customer issues, or attend trade shows.

Makes determinations based on facts. Identifies problems, reports potential problems, and assesses options.

Remain flexible to meet constantly changing and sometimes opposing demands.

This job description in no way states or even implies that these are the only duties

Certified Welding Inspector (CWI)

Buffalo, NY

Up to $90,000 + Benefits

Structural Steel

Why This Role Matters:

Your expertise ensures the quality and reliability of complex structural steel projects, verifying that every weld, joint, and fabrication meets the highest standards of safety, compliance, and workmanship.

Key Responsibilities:

• Perform weld inspections to AWS, ASME, ISO, and client standards
• Conduct visual, dimensional, and non-destructive testing (VT, PT, MT, UT)
• Interpret welding procedures, blueprints, and technical specifications
• Identify and resolve quality concerns with production and engineering teams
• Maintain accurate inspection records, logs, and reports
• Audit welding processes for compliance and best practices
• Support welders with training on quality requirements and standards

Ideal Candidate Profile:

• AWS Certified Welding Inspector (CWI) – required
• Experience in structural steel, shipbuilding, or heavy fabrication
• Strong knowledge of welding codes (AWS D1.1, ASME Section IX, etc.)
• Proficiency in NDT methods (ASNT Level I/II preferred)
• Skilled at interpreting weld symbols, drawings, and blueprints
• Detail-oriented with strong communication skills

Submit resume to or apply online.

Kelly Science & Clinical is seeking Bioanufacturing Associates for multiple direct hire opportunities with one of our clients, a biotechnology company that develops and manufactures novel synthetic DNA tools at its state-of-the-art manufacturing facility in Wilsonville, OR. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Pay rate: $21/hour + shift differential + overtime

Schedule:

• 2A: Alt Saturday, Sunday - Tuesday (7:00 pm-7:30 am)
• 2B: Wednesday - Friday, Alt Saturday (7:00 pm-7:30 am)

Workplace: Onsite in Wilsonville, OR

Overview

We are looking for motivated Bioanufacturing Associates for one of our clients, a biotechnology company that developed a disruptive synthetic biology technology. The incumbent will perform basic molecular biology workflows in a highly automated, high-throughput manner and will be responsible for the manufacture of a variety of custom oligonucleotide products. The ideal candidate will be able to work independently, be very neat and organized, have the ability to follow established SOPs, and complete manufacturing batch records to contribute to the daily production schedule. The ideal candidate will be driven and will do what it takes to keep manufacturing on track in a fast-paced start-up environment. The Manufacturing Associate will be responsible for the production of custom gene-based products and/or various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule. They will uphold standards as defined by the manufacturing process, work on continuous improvement and have good time management resulting in efficiency, and work in a safe manner.

Responsibilities

• Manufacture high-quality custom oligo-containing products in a high-throughput manufacturing lab according to established SOPs.
• Operation of robotic laboratory equipment and traditional lab equipment (bioanalyzers, centrifuges, sealers, thermocyclers, spectrometers, HPLCs, Next-Generation Sequencing, etc.)
• Daily use of traditional molecular biology processes and techniques, especially PCR, DNA quantitation and handling, and DNA purification
• Maintaining thorough, accurate, and detailed documentation of all work produced in batch records, databases, or other acceptable formats, including problems and deviations
• Updating and writing work instructions and documentation
• Ability to work independently and in a safe manner
• Attention to detail for process consistency
• Documentation, troubleshooting, and addressing process deviations
• Packaging products
• Ability to work in an ISO, GMP, LEAN manufacturing environment and follow the lean manufacturing concepts
• Daily completion of assigned tasks to keep manufacturing on track

Qualifications

• Bachelor's/Associate's degree in biology, chemistry,or biochemistry: degree preferred, but will consider candidates with relevant laboratory experience
• Familiarity or prior experience in a manufacturing environment
• Good written and verbal skills
• Attention to details
• Good computer skills and comfort in using computers for all aspects of manufacturing, experience with Excel and Word, Jira/Confluence, and web-based or similar programs

Senior SCADA Engineer

We are a Houston-based manufacturing and energy company seeking a Senior SCADA Engineer to lead the design, implementation, and support of VTSCADA and real-time operational systems for distributed energy assets.

We are seeking a Senior SCADA Engineer to lead the design, implementation, integration, and administration of VTSCADA and real-time operational systems supporting distributed energy assets. This role combines technical leadership, system ownership, and team guidance to design scalable SCADA architecture that ensures reliability, reduces downtime, and supports fleet growth.

Key Responsibilities:

• SCADA Architecture & System Ownership: Lead SCADA system design, development, and maintenance; set standards for telemetry, alarms, and data integrity; provide technical oversight and serve as escalation authority; ensure compliance with cybersecurity and operational standards.
• Grid & Utility Integrations: Design ICCP integrations and telemetry models for utility and market participation; ensure secure, reliable data flow with external entities.
• Real-Time SCADA Operations: Oversee engineering, commissioning, and operational support for SCADA systems; maintain uptime and performance; review site SCADA designs and configurations; support system upgrades and enhancements; collaborate with IT and Operations for secure infrastructure.
• Continuous Improvement: Drive automation, tooling, and database improvements; strengthen change management and governance processes; enhance system reliability and operational performance.

Required Qualifications & Experience:

• Bachelor's degree in Electrical, Computer, or related Engineering/Science field (or equivalent experience)
• 7+ years SCADA engineering experience (VTSCADA, Siemens, Emerson, or similar) in energy or utility environments
• 5+ years supporting real-time operational systems
• Hands-on ICCP/utility data exchange experience (ERCOT, RTOs, ISOs)
• Experience with Autosol ACM or similar utility-grade SCADA platforms
• Strong understanding of grid operations, telemetry architecture, and distributed energy/microgrid systems
• Proficiency with distributed systems, Windows servers, networking, cybersecurity, and relational databases (e.g., MS SQL)
• Experience leading technical projects, mentoring engineers, and establishing governance standards
• Demonstrated track record improving system reliability, reducing operational risk, and enhancing real-time system performance

Benefits:

• Competitive medical, dental, and vision coverage
• Company-paid life and disability insurance
• Paid time off and family leave options
• 401(k) retirement plan with match
• Wellness initiatives and employee perks

Senior Technology Risk Management Associate

Location: New York (Hybrid – 3 days onsite)

I’m working with a well-established global alternative investment firm that is looking to add a Senior Technology Risk Management Associate to their technology organization. This role sits at the intersection of technology, security, and risk, working closely with infrastructure, security, and business teams to help strengthen governance and risk management practices across the environment.

The position is a mix of hands-on risk assessment, audit support, and process improvement, with exposure to both traditional infrastructure and cloud-based systems.

What You’ll Be Doing

• Partner with technology and security teams to identify and manage technology risks
• Support external audits and regulatory reviews, including documentation and walkthroughs
• Evaluate technology controls and security processes and help improve them
• Conduct risk assessments of applications, infrastructure, and third-party services
• Track and coordinate risk remediation efforts with internal teams
• Help maintain an inventory of systems and services while identifying potential control gaps
• Contribute to automation and process improvement initiatives
• Provide reporting and updates to technology leadership

What They’re Looking For

• ~5+ years of experience in technology risk, information security, IT audit, or compliance
• Strong understanding of technology environments (infrastructure, applications, cloud)
• Experience working with risk frameworks or audit processes
• Ability to translate technical risks into business impact
• Strong communication and collaboration skills

Nice to Have

• Exposure to cloud environments (Azure or AWS)
• Familiarity with Windows infrastructure or database environments
• Experience with automation or scripting (PowerShell or Python)
• Knowledge of frameworks like SOC, ISO, NIST, or SOX
• Security or risk certifications (CISA, CISSP, CRISC, etc.)

Compensation

Base salary typically falls in the $150k – $175k range, plus bonus and strong benefits.

The Phoenix Group Advisors is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace and prohibit discrimination and harassment of any kind based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. We strive to attract talented individuals from all backgrounds and provide equal employment opportunities to all employees and applicants for employment.

We’re looking for a Senior Design Assurance Engineer in Maple Grove, MN to support innovative medical device development. You’ll lead design assurance activities, ensure compliance with regulatory standards, and collaborate with cross-functional teams to bring safe, high-quality products to market.

Ideal candidates: 5+ years in design assurance, strong knowledge of FDA/ISO/IEC regulations, experience with risk management and design controls, and excellent problem-solving skills. Experience with DHF, DMR, and technical files.

Staff Design Quality Engineer – Class III Implantable Medical Device

San Francisco Bay Area | Full-Time | Hybrid

A fast-growing medical device company developing next generation implantable technology is expanding its engineering team and hiring a Staff Design Quality Engineer to support the development of a highly innovative Class III medical device platform.

This is a highly technical, hands-on role embedded directly with R&D, focused on ensuring quality is built into product development from early feasibility through clinical and commercial stages.

You will play a key role in helping bring a breakthrough therapy to market while working alongside experienced engineers and cross-functional leaders in a collaborative development environment.

Responsibilities

• Partner closely with R&D and systems engineering teams to integrate design quality into product development
• Lead and support design control activities throughout the product lifecycle
• Drive risk management efforts (ISO 14971) including hazard analysis, FMEAs, and risk mitigation strategies
• Support verification and validation planning and execution
• Ensure compliance with FDA design control requirements and global quality standards
• Participate in cross-functional design reviews and technical decision making
• Help translate regulatory and quality requirements into practical engineering processes

Qualifications

• BS or MS in Engineering (Biomedical, Mechanical, Electrical, or related)
• 7+ years of experience in medical device product development or design quality
• Strong experience with design controls and risk management
• Experience supporting Class II or Class III medical devices
• Ability to collaborate closely with R&D in early-stage product development
• Experience supporting IDE, PMA, or complex regulatory pathways is highly valued

What Makes This Opportunity Unique

• Work on cutting-edge implantable technology
• Join a highly technical engineering-driven team
• Be involved early in the development lifecycle
• Significant opportunity for technical ownership and influence
• Competitive compensation, bonus, and equity package

If you are interested in learning more, feel free to reach out directly.