Senior Quality Engineer - Combination Product Development

Role Summary

Lead quality engineer for medical device combination product development projects, focusing on design control and risk management. Collaborate with device engineering on verification, validation, and transfer activities. Drive quality improvement and ensure compliance with FDA/ISO standards and the company quality system. Serve as escalation point for complex quality issues and support relationships with CMOs and cross-functional teams.

• Serve as a lead quality engineer for medical device combination product development projects, with a strong emphasis on design control and risk management activities.
• Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities.
• Contribute to quality improvement initiatives and ensure compliance with relevant regulations and standards, including FDA 21 CFR Part 820, 21 CFR Part4, ISO 13485, ISO 14971, and Gilead’s quality system requirements. Plan and implement approved quality improvement action items and deliverables.
• Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex technical issues related to drug-device combination products, processes, and quality.
• Act as an escalation point for complex and high-impact quality issues, concerns, and decisions.
• Support strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMOs).
• Provide guidance and impact assessments for change controls, including Design History File (DHF) and Risk Management File (RMF) assessments.
• Develop and/or review controlled documents (e.g., protocols, reports, plans, risk analyses, specifications, test methods).

• Required:
  
  Bachelor's degree in engineering or a scientific discipline with at least 6 years of relevant experience, OR a Master's degree in a relevant field with at least 4 years of relevant experience.
• Required:
  
  Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products.
• Required:
  
  Excellent verbal, written, and interpersonal communication skills.
• Preferred:
  Prior experience with combination products (e.g., autoinjectors, co-packed kits, pre-filled syringes).
• Preferred:
  Strong project management and process improvement skills.
• Preferred:
  Understanding of domestic and international quality system regulations and the ability to drive continuous improvement.
• Preferred:
  Foundation in statistical techniques (e.g., normality tests, capability analysis, tolerance intervals), test method validation (MSA, GageR&R), and risk management principles per ISO 14971, including FMEA and systems analysis. Expertise in one of these areas is required.
• Preferred:
  Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles and theories.
• Preferred:
  Strong knowledge of medical devices and/or combination products manufacturing.

• Bachelor's degree in engineering or scientific discipline (required) or Master's degree in a relevant field with equivalent experience.

• Quality assurance for medical devices and/or drug-device combination products
• Design control and risk management, including DHF and RMF assessments
• Regulatory standards: FDA 21 CFR Part 820, Part 4; ISO 13485; ISO 14971
• Documentation development and review (protocols, reports, plans, risk analyses, specifications, test methods)
• Stakeholder management and collaboration with internal teams, contract manufacturers, and suppliers
• Statistical methods: normality tests, capability analysis, tolerance intervals; MSA and Gage R&R