Job Details

Responsibilities:

• Ensure all design control activities for new and updated products meet company procedures and global regulatory requirements.
• Lead risk management activities, including hazard analysis, FMEAs, and risk documentation.
• Support sterilization and biocompatibility assessments.
• Own and maintain design control documentation.
• Partner with R&D, Regulatory, Manufacturing, and Project Management to ensure quality is built into every stage of product development.
• Maintain accurate test, validation, and risk records and report progress to leadership.
• Support regulatory submissions (e.g., 510(k), CE Mark).
• Lead root cause investigations and corrective actions related to design issues.
• Support complaint investigations, nonconformances, and CAPAs after product launch.
• Conduct DHF audits to ensure phase completion requirements are met.
• Review and approve engineering documents and test reports.
• Identify opportunities to improve product quality, reduce cost, and increase efficiency.

Requirements

• Bachelor's degree in Engineering or related field.
• 10+ years of quality engineering experience in medical devices, including new product launches.
• Experience with sterilization and biocompatability
• Strong knowledge of design controls, risk management, and medical device regulations (FDA, ISO, IEC).
• Experience with verification & validation (V&V) and FMEAs.
• Strong problem-solving and statistical analysis skills (e.g., Minitab, JMP).
• Detail-oriented with strong documentation skills.
• Quality certifications (CQE, CSQE, Six Sigma) are a plus.