Senior Device Quality Engineer
Hybrid · Zebulon, North Carolina, United States
Job Summary
Lead activities to ensure safety, regulatory, and quality compliance for medical devices within combination products. Responsibilities include maintaining risk management files (ISO 14971) and Design and Development File (ISO 13485), reviewing/approving technical documentation and quality plans, supporting new product development, leading investigations for nonconformances, deviations, and complaints, monitoring site KPIs, and preparing for regulatory inspections. Partner with suppliers and internal teams to resolve component quality issues, support supplier quality management, and drive lifecycle management, continuous improvement, and design controls. The role is on-site with hybrid flexibility based on site needs, offering opportunities to lead projects and broaden technical and leadership skills.
Required Qualifications
- Bachelor’s degree in a scientific, engineering, or technical discipline
- Minimum 8+ years of relevant experience in pharmaceutical/biopharmaceutical or related industry
- Direct experience in manufacturing and quality oversight of medical devices
- Experience conducting investigations, root cause analysis, and managing CAPA processes
- Working knowledge of Quality Management Systems (QMS) and current Good Manufacturing Practice (cGMP) regulations
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.