Senior Quality Engineer

We are seeking a Senior Quality Engineer to join our team. The successful candidate will have experience in medical device quality engineering with a focus on design assurance. They will be responsible for implementing and maintaining QSR and ISO 13485 quality systems and qualification activities. The candidate will also support the development and implementation of quality systems and compliance activities.

Requirements

• Bachelor's degree in Engineering, Biomedical Engineering, or a related field
• Minimum 10 years in medical device quality engineering with a focus on design assurance
• Strong understanding of ISO 13485, FDA 21 CFR Part 820 & Part 11, EU MDR, ISO 14971 (Risk Management), ISO 10993-1 Biocompatibility, FDA/EU/UK Food Safe Regulations, WERCSmart, RoHS compliance
• Experience with risk management tools (FMEA, Hazard Analysis), design verification/validation, and statistical methods
• Proficiency in MS Office, Quality Management Systems (QMS), and statistical tools (Minitab, Tableau)
• Strong analytical, problem-solving, and cross-functional collaboration skills

Benefits

• Generous Paid Time Off
• 401k Matching
• Tuition Reimbursement
• Relocation Assistance