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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

• Lay out, build, test, troubleshoot, repair and modify developmental and production electronic components, parts, equipment, and systems • Troubleshooting servo drives • Troubleshooting servo motors • Troubleshooting machinery • Performs preventative maintenance • Maintaining Vision Systems • Perform other duties as required or requested by management.

• Associate's Degree in related field; or two to four years related industry experience and/or training; or equivalent combination of education and experience.

• Capable of reading and understanding PLC programs, such as Siemens, Beckhoff, Moller, Allen Bradley.

• Ability to read wiring schematics • Basic mechanical skills to include hydraulics and pneumatics understanding • Understanding of the work principles of sensors, proxes, vision • Knowledge and understanding of electricity • Must be comfortable performing work between 0 and 480 volts • Understanding of Ethernet and Ethercat • Basic mechanical skills to include hydraulics and pneumatics understanding • Knowledge of relay logic circuits, PMA Controllers, PID Controller and MotoMan Robotics • ze: 12px;">Basic mechanical skills to include hydraulics and pneumatics understanding • Knowledge of relay logic circuits, PMA Controllers, PID Controller and MotoMan Robotics • Experience or Training in 5's, Lockout & Tagout training, Basic Plant Safety, General Machine Operations.

• Based on competence and need, training or knowledge in Hazardous Waste, ISO 14001 Awareness, ISO 14001 Internal Auditing, ISO 14001 & Beyond, ISO 14001 Top Management, HazWaste/Operator Program Training, HazWaste Manifest and Core Program Training, HazWaste/Crisis Management Training.

Must be familiar with Quality, Materials, Environmental, and Safety Policies.

The primary purpose of this job is to strategically plan, execute and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.

Key Accountabilities and Responsibilities:

• Adheres to Integer's Core Beliefs and all safety and quality requirements.
• Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
• Provides strategic input. Participates on Product Development teams, providing a high level of experience in regulatory, strategy, timelines, and direction.
• Prepares US and International submissions and work with government agencies and/or distributors to obtain product approval/clearance.
• Serves as informational resource for all departments, assisting in keeping company informed of US and International regulatory requirements. Ensures relevant International, ISO and FDA Export requirements are met, as required and ensures accuracy of submission information.
• Initiates FDA export approval requires and product release authorizations.
• Reviews ECO's and assess effect of product changes on US and International regulatory strategy and submissions per standard procedures.
• Evaluates post-market incident reports and determine MDR requirements.
• Assists with recall/retrieval documentation and other activities.
• Develops and maintains regulatory status documents and submission procedures.
• Identifies, investigates, evaluates and implements as appropriate new methodologies associated with product quality and quality systems.
• Performs other functions as required.

Job Requirements:

• Minimum Education: Bachelor's degree in a related field.
• Minimum Experience: 7+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA, and TPD experience.
• Specialized Knowledge: Knowledge of FDA Quality System regulations and ISO requirements. Knowledge of all applicable laws which regulate medical device manufacturers. Ability to work through difficult issues with suppliers and customers.
• Special Skills: Strong communication and technical writing skills. Skill in management, precision measurement, auditing, training, supplier/customer relations, FDA inspections, ISO 9000.
• Other: Skill in working with computers and experience with spreadsheet and word-processing software.

Salary range $113,025 - $165,770

Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer's success. Our compensation program includes base salary and a cash-based incentive program supporting our pay-for-performance philosophy. We provide a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits. Parental leave is available after one year. Optional employee-paid programs include supplemental life insurance, critical illness, hospital indemnity and accident insurance. Employees are immediately eligible to participate in the 401(k) plan with company matching contributions. We provide 80 hours (10 days) of company designated holidays per year plus an annual allotment of paid time off.

U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.

We have partnered with a top manufacturer in Lewistown, PA, looking to add a Health and Safety Manager to their team! Our client is a top homebuilding company in the country!

This is an on-site/full-time/direct hire position

Position Summary: The successful employee in this role is accountable for the environmental, health, and safety functions for the home building facility. This role implements and ensures compliance with environmental and safety training activities and programs intended to create a safe and healthful workplace. This position influences plant GM, PM, Area Coordinators, Team Leaders, and Team Members to improve plants' environmental and safety efforts. The employee in this role works with Home Office management with respect to environmental and safety training programs as required. This role monitors and maintains environmental, safety, and health programs for plant team members.

Duties / Responsibilities:

Environmental:

• Maintain all record keeping and conduct activities necessary for environmental compliance (monthly material usage record keeping, storm water, air permitting, etc).
• Walk through with environmental consultant (STRATA) personnel during scheduled visits. Complete Annual Stormwater and other required training.
• Champion the ISO certification/surveillance efforts to include leading the EHS Committee and participating in the Objectives and Targets Team Meetings
• Lead the ISO Coordinator and, when not available, conduct their duties (see Environmental/ISO Coordinator job description_

Health

• Champion the team's health efforts by working with wellness coordinators to promote good eating habits, physical fitness, and mental health.
• Set a great example for the team by continuing to improve one's personal wellness

Safety / Workers' Compensation

• Conduct and complete the Injury and Illness report with the injured team member, Area Coordinator, and Team Leader or Manager after completing a thorough accident investigation.
• Ensure post-accident drug screens are completed as required.
• Call in, fax, or e-mail First Report of Injury to Broadspire within 24 hours of the accident, or sooner.
• Act as workers' compensation liaison and participate in quarterly reviews of loss runs. Complete and maintain OSHA 300 Log record keeping.
• Administer the company's Return-to-Work program, including the transitional employment teams.
• Report to Home Office EHS Director monthly reporting numbers: (OSHA entries for the previous month, Lost Time Accident, and OSHA streaks in number of days).
• Administer the workers' compensation program, which includes working with the company's insurance carrier to reduce lost time and fraudulent claims, case management, and communications with team members.
• Maintain active involvement in teams' safety committee functions by coordinating monthly meetings and inspections, ensuring the recording of minutes, and coordinating changes based on committee feedback and inspection results.
• Walk through with property carrier loss control personnel during scheduled visits. Provide a written plan of action within 30 days to the property carrier representative and the Home Office EHS Director.
• Walk through with Fortier loss control personnel during scheduled visits and complete all corrective actions within 30 days or less.
• Conduct regular safety meetings with area coordinators and team leaders to review and discuss each group's accidents and injuries. Identify ways to prevent recurrence of accidents by reengineering, changing the process, or providing personal protective equipment.
• Conduct facility inspections to detect existing or potential safety hazards and make recommendations regarding corrective or preventive measures to management.
• Ensure compliance with all applicable OSHA standards and regulations, such as Hazard Communication,
• Lockout/Tag out, Bloodborne Pathogens, Hearing Conservation, Emergency Evacuation Plans, etc., utilizing the Home Office EHS Director as a resource.
• Ensure compliance with company and home building facility policies and procedures relating to Scissor Lifts, Fall Protection, Line Roll, Hitch Lock, Hot Works, Suspended Loads, Saw Safety, etc., utilizing the
• Home Office EHS Director as a resource.
• Participate in and follow up on the investigation of work-related injuries/illnesses, on-the-job accidents, or near misses as required.
• Complete Near Miss and/or Lost Time Accident Case studies and send to Home Office EHS Director.
• Administer Hearing Conservation Program.
• Conduct annual Job Hazard Analysis and provide feedback to all affected teams.
• Ensure team members who are First Responders are trained in First Aid, CPR, and AED; and are certified by State and Federal laws as required.
• Maintain current MSDS (Material Safety Data Sheet) master binder. Provide individual binders for the designated teams in the manufacturing facility.

Training

• Develop and conduct required OSHA training programs on plant work practices, safety precautions, and procedures as required.
• The Safety and Health Manual requires updating, ensuring procedures are consistent with written programs.
• Make necessary changes as needed and keep the team informed.
• Maintain team member records for all completed safety training.
• Develop and conduct safety training as required by State and Federal law, regulations, etc.
• Ensure all forklift, tractor, and other associated powered industrial truck operators are effectively trained and licensed to operate safely as required by OSHA and applicable State and Federal laws.
• Conduct effective New Hire Orientation safety training.

Qualifications:

• Bachelor's degree in Environmental Studies or related field.
• 3-5 years of related experience.
• Bilingual Spanish-speaking is preferred, but not required.
• General understanding and knowledge of federal, state, local, and company regulations and standards applicable to Environmental Protection Agency (EPA) and Occupational Health and Safety (OSHA) practices and programs, state workers' compensation programs, and ISO program familiarity.
• Experience in safety culture and industrial environment strongly preferred.
• Great people/leadership skills required.
• Excellent presentation skills required.
• Microsoft Office, Excel, and PowerPoint Skills.

Applicants must be authorized to work in the U.S.

We are an equal-opportunity employer. We do not discriminate in hiring or employment against any individual on the basis of race, color, gender, national origin, ancestry, religion, physical or mental disability, age, veteran status, sexual orientation, gender identity or expression, marital status, pregnancy, citizenship, or any other factor protected by anti-discrimination laws.

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.

#ZR

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.

Location: Lyndhurst, NJ (in-office preferred; flexibility may be available depending on fit)

Type: Full-time

About Tekcard Payments

Tekcard Payments is a payment processing and technology company supporting merchants nationwide and a growing ISO/partner channel. We run a fast-paced operation where everyone wears multiple hats and client experience matters.

The Role (Not Generic “Customer Service”)

We’re hiring a Payments Client Services Analyst to support merchants and partners across day-to-day servicing, onboarding coordination, and light operations tasks. This is a B2B, finance-operations style support role—ideal for someone coming from banking, accounting support, fintech, merchant services, or other detail-driven client operations.

You will handle merchant requests, coordinate with internal teams (Underwriting/Risk/Tech/Accounting), and keep accounts moving. You may also support our Premier ISO/Partner channel with status updates, documentation requests, and basic system tasks.

What You’ll Do

• Merchant Support (B2B): Handle inbound merchant questions via phone/email/ticketing—funding/deposit questions, batching, statements, charge schedules, and general account support.
• Partner / ISO Channel Support: Assist partners with onboarding status, missing items, and basic platform/process questions (with clear escalation paths).
• Light Operations / Account Maintenance: Update merchant profiles (bank updates, ownership changes, contact changes), help key/confirm data in internal systems, and ensure clean documentation.
• Issue Triage + Escalation: Identify what’s a client education issue vs. a technical issue vs. a risk/underwriting issue; escalate with clean notes and supporting details.
• Chargeback/Dispute Assistance: Guide merchants on dispute documentation and timelines; route cases appropriately.
• Documentation & Case Notes: Maintain accurate notes, checklists, and follow-ups so nothing falls through the cracks.

You’re a Strong Fit If You…

• Communicate clearly and professionally (written + verbal).
• Are organized and comfortable working multiple queues at once.
• Like structured work: checklists, documentation, clean notes, follow-ups.
• Can learn systems quickly (CRM/ticketing, portals, spreadsheets).
• Can stay calm when a merchant is stressed about money/timing.

Relevant Backgrounds That Translate Well

We’re intentionally trying to avoid “retail-only customer service.” Strong backgrounds include:

• Bank branch operations, deposit ops, treasury support, ACH support
• Accounts receivable / billing support / client accounting support
• Mortgage servicing support / loan operations / escrow processing
• Merchant services support, fintech support, payment operations
• B2B customer support where accuracy + documentation mattered

Requirements

• 1–3+ years in a client-facing operations role (banking, fintech, accounting support, merchant services, etc.)
• Strong attention to detail and comfort with systems + Excel/Google Sheets
• Ability to handle sensitive information with professionalism and discretion

Nice to Have

• Payments/merchant services exposure (funding, batching, statements, chargebacks)
• Experience supporting partners/agents/ISOs (B2B channel support)
• Familiarity with onboarding workflows and verification steps
• Equal Opportunity Employer: Tekcard Payments is an equal opportunity employer.

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.