Senior Device Quality Engineer

Position Summary

This position ensures products meet safety, regulatory, and quality standards throughout the product lifecycle, from design and development to post‑market surveillance for medical devices within combination products. Responsibilities include risk management, participation in root cause analyses, process validation, and maintaining Design and Development Files (DDF) related to medical devices.

• Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products.
• Maintain and improve risk management files (ISO 14971) and Design and Development File (ISO 13485).
• Review/Approve technical documentation, quality plans, and support new product development and introduction.
• Support process improvements, validations and ensure production complies with required specifications for medical device manufacturing (filling, assembly and packaging) within combination products.
• Lead investigations for device‑related nonconformances, deviations, and complaints.
• Monitor and trend site KPIs for device processes, identify risks, and support development of mitigation strategies focused on patient safety and quality.
• Lead site inspection readiness for device related areas and act as the subject matter expert for regulatory inspections and audits.
• Partner with suppliers and internal teams to resolve component quality issues and support supplier quality management.
• Support device lifecycle management activities, including continuous improvement, design changes, post‑market quality monitoring, and the maintenance and compliance of the Design and Development File (DDF).
• Act as site Subject Matter Expert (SME) for device quality processes, providing guidance to operations, engineering, and quality teams.

We seek clear communicators who care about quality and patient safety. You will join a collaborative team that values learning and personal growth. The role is on‑site with hybrid flexibility where local site needs allow. You will have opportunities to lead projects, broaden technical skills, and influence quality practices across functions.

• Bachelor’s degree (BA/BS) in a scientific, engineering, or technical discipline, with demonstrated medical device expertise or equivalent combination of education and experience.
• Minimum of 8+ years of relevant experience in the pharmaceutical, biopharmaceutical, or related industry, including direct experience in manufacturing and quality oversight of medical devices.
• Demonstrated hands‑on experience conducting investigations, performing root cause analysis, and managing Corrective and Preventive Action (CAPA) processes.
• Working knowledge of Quality Management Systems (QMS) and current Good Manufacturing Practice (cGMP) regulations.

• Communication &
  
  Collaboration:
  
  Strong written and verbal communication skills, with the ability to effectively collaborate and influence across cross‑functional teams.
• Regulatory & Audit Support: Experience supporting audits and regulatory inspections, including preparation, coordination, and response management.
• Device Assembly Expertise: Preferred experience in the management and oversight of pre‑filled syringe and autoinjector assembly processes.
• Design & Development Knowledge: Working knowledge of design controls, risk management, and Design and Development File (DDF)/Design History File (DHF) requirements.
• Regulatory Knowledge: Understanding of global regulations, regulatory expectations, inspection practices, emerging technologies, and industry standards related to medical devices and combination products.
• Quality Systems
  
  Experience:
  
  Experience with change control, process validation, investigations, root cause analysis, and CAPA management for quality and manufacturing issues.
• Advanced
  
  Education:
  
  Advanced degree in Engineering, Biomedical Engineering, or a related discipline preferred.
• Risk Management & Human Factors: Experience with human factors engineering, design controls, and device risk management (e.g., ISO 14971).
• Regulatory Familiarity (U.S.): Familiarity with device‑specific standards and regulatory requirements in the…