Sr. Quality Engineer

This position serves as the primary Quality Assurance (QA) resource responsible for supporting the implementation and ongoing effectiveness of the Quality System. The role performs a wide range of quality-engineering activities and support tasks aligned with business objectives, while developing and applying expertise in 21 CFR 820 and 803, ISO 9001/13485, and EU MDR.

Requirements

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field)
• 5+ years of experience in Quality Engineering within the medical device industry
• Strong understanding of FDA QSR (21 CFR Part 820), ISO 13485, and other relevant medical device regulations and standards
• Proven experience with design controls, risk management (ISO 14971), process validation (IQ, OQ, PQ), and statistical process control (SPC)

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship