Senior Quality Engineer- Combination Product Development

Senior Quality Engineer
- Combination Product Development

• Serve as a 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 Part 4, 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).

Qualifications:

• 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.
• Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products.
• Prior experience with combination products (e.g., autoinjectors, co-packed kits, pre-filled syringes) is preferred.
• Strong project management and process improvement skills.
• Understanding of domestic and international quality system regulations and the ability to drive continuous improvement.
• Knowledge of basic statistical techniques (e.g., normality tests, capability analysis, tolerance intervals) is preferred.
• Experience with test method validation (MSA, Gage R&R) is preferred.
• Experience with risk management principles according to ISO 14971, including the use of risk management tools such as FMEA and systems analysis, is highly desirable.
• Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles and theories.
• Strong knowledge of medical devices and or combination products manufacturing.
• Excellent verbal, written, and interpersonal communication skills.