Sr Quality Engineer I

Gilead Sciences, Inc. • Foster City, CA

32d

About The Position

This opportunity is an exciting and challenging role that will be key to Gilead's success as we work towards bringing new combination products, such as pre-filled syringes and autoinjectors, to market. As a Sr Quality Engineer I , you will be a key Quality person who ensures compliant processes are in place to support the successful implementation and execution of Gilead's combination product lifecycle management.

Requirements

• Bachelor's degree in science or engineering-related field with at least 6 years of experience in the medical device industry, OR Master's degree with at least 4 years of relevant experience.
• In-depth knowledge of Quality principles, concepts, industry practices, and standards.
• Quality experience in both clinical and commercial products.
• Strong understanding of U.S. and international quality systems regulations/standards.
• Ability to work independently and in a global team environment.
• Excellent interpersonal and communication skills.

Nice To Haves

• Previous experience with combination devices (e.g., autoinjectors, pre-filled syringes).
• Well-versed in risk management methodologies and tools (e.g., Hazard Analysis, FMEA).
• Knowledge of ISO 14971 Risk Management processes.
• ASQ certifications (Certified Quality Auditor, Certified Quality Engineer, Certified Quality Manager) or equivalent.
• Familiarity with emerging regulatory requirements and ability to drive continuous improvement initiatives.

Responsibilities

• Develop key relationships and interface extensively with internal stakeholders to address and resolve quality and compliance issues related to drug-device combination products.
• Identify gaps in existing processes and lead cross-functional teams to develop and implement solutions.
• Write and/or implement changes to controlled documents (e.g., SOPs, Specifications, Work Instructions).
• Work with management and department personnel to achieve goals and strategic initiatives.
• Identify, plan, and execute changes to quality processes to ensure conformance and continuous improvement.
• Ensure changes to commercial products comply with FDA QSR/QMSR, ISO 13485, and other applicable standards.
• Maintain compliance with global Risk Management processes in accordance with ISO 14971 and other applicable standards.
• Collaborate with SMEs from R&D, Clinical, and Operations to ensure comprehensive application of risk processes.
• Participate in annual product reviews and periodic updates of DHF and RMF.
• Maintain expertise in current and emerging requirements and quality trends for Pharmaceuticals, Medical Devices, and Combination Products worldwide.
• Support due diligence and internal/external audits or inspections as needed.
• Assist with complaint investigations and communicate findings to design, development teams, and CMOs.
• Stay abreast of evolving regulatory requirements to ensure compliance of commercial products.
• May support design and development activities as required.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees