Senior Product Quality Engineer

We are seeking a Senior Product Quality Engineer to provide engineering support for on-market medical devices, lead complaint investigations, and drive the implementation of corrective and preventive actions to improve product performance.

Requirements

• Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management).
• Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Knowledge of root cause analysis tools and risk-based decision-making processes.
• Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues and improve product performance.
• Strong data analysis and trending skills to identify patterns, assess risks, and recommend mitigations.
• Ability to manage and implement design or process changes, including testing, documentation, and change control.
• Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
• Ability to collaborate with cross-functional teams, including Operations, Engineering, and R&D, to drive improvements in product design and manufacturing processes.

Benefits

• Annualized base salary range $97,600-$152,700
• Bonus eligible