Sr Quality Engineer II - Combination Products

仕事内容

Key Responsibilities

• Serve as a Lead Quality Engineer for medical device combination product development programs, with a strong focus on design controls, risk management, and lifecycle quality oversight.

• Partner closely with Device Engineering on new combination product development, supporting design verification, design validation, and technology transfer activities.

• Ensure compliance with applicable regulatory requirements and standards, including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead Quality System requirements.

• Plan, implement, and track approved quality improvement initiatives, ensuring timely execution of action items and deliverables.

• Interface with internal cross‑functional teams, contract manufacturers, and suppliers to resolve complex technical and quality issues related to drug‑device combination products, processes, and manufacturing.

• Act as an escalation point for complex, high‑impact quality issues, risks, and decisions.
• Support and strengthen strategic relationships with internal stakeholders and Contract Manufacturing Organizations (CMOs).

• Provide quality guidance and impact assessments for change controls, including evaluations of Design History Files (DHF) and Risk Management Files (RMF).

• Develop, review, and approve controlled documentation, including protocols, plans, reports, risk analyses, specifications, and test methods.

Basic Qualifications

• Bachelor’s degree in Engineering or a scientific discipline with at least 8 years of relevant experience, OR

• Master’s degree in a related field with at least 6 years of relevant experience.

• Demonstrated experience in Quality Assurance for medical devices and/or drug‑device combination products.

• Excellent verbal, written, and interpersonal communication skills, with the ability to influence across functions.

Preferred Qualifications

• At least 10 years of experience supporting combination products (e.g., autoinjectors, pre‑filled syringes, co‑packaged kits), with deep expertise in design controls and risk management.

• Strong project management and process improvement capabilities.

• Working knowledge of domestic and international quality system regulations and the ability to drive continuous improvement in regulated environments.

• Strong foundation in statistical methods, including normality testing, capability analysis, tolerance intervals, and test method validation (MSA, Gage R&R).

• Advanced proficiency in risk management per ISO 14971, including FMEA, system‑level risk analysis, and hazard analysis (expertise in at least one area required).

• Ability to develop and evolve complex quality concepts, standards, and methodologies based on sound quality engineering principles.

• Strong knowledge of medical device and/or combination product manufacturing operations.