Sr. Quality Engineer II - Combination Products

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.