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Quality Engineer (Medical Device Compliance & Regulatory Affairs)
Visa Sponsorship
AI Summary
Lead quality management processes and regulatory compliance for FDA/EU MDR Class II medical devices, ensuring adherence to ISO 13485 and QMSR standards. Collaborate with product teams on design controls, risk management, and process improvements while supporting audits, inspections, and CAPA activities. Requires 3-5 years of medical device QA experience with strong compliance expertise.
Key Highlights
Regulatory compliance for FDA/EU MDR Class II medical devices under ISO 13485 and QMSR
End-to-end quality management, including design controls, risk analysis (ISO 14971), and CAPA
Active participation in FDA/EU audits, inspections, and internal training
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Key Responsibilities
Maintain and update quality management processes to meet FDA/EU MDR and ISO 13485 requirements
Collaborate with product teams on design inputs/outputs, design reviews, verification/validation, and design transfer
Ensure compliance with design controls and risk management (ISO 14971) throughout the product lifecycle
Support manufacturing process controls, change control, and production quality assurance
Investigate nonconformances, conduct root cause analysis, and drive CAPA activities under Quality Manager guidance
Participate in ISO/EU MDR audits and FDA inspections
Develop and deliver QA-related internal training programs
Technical Skills Required
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Benefits & Perks
Competitive salary ($90,000 - $115,000)
Performance-based incentive stock options
Medical, dental, and vision insurance
401k plan
Flexible spending accounts (Section 125)
Paid vacations
H-1B visa sponsorship
Job Description
A Quality Engineer position is available on-site at EDDA Technology in Princeton, NJ. Responsibilities include:
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