Sr Product Quality Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Title: Sr Product Quality Engineer

When your part of the team at Thermo Fisher Scientific, you will do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you will be supported in achieving your career goals.

Position Summary:

The Sr Product Quality Engineer is responsible for providing support and guidance to the LSMS Business Unit. The Product Quality function is responsible for coordinating and driving Quality improvements at the Business Unit. As well as ensuring these improvements drive the warranty cost reduction at the Business Unit and monitoring of quality processes are carried out as per the applicable standards. 

Key Responsibilities: 

• Fosters a quality culture to achieve Business Unit-wide program success through measurable activity, metrics, and strong ability to influence teams in the areas of focus.
• Drives consistent adoption of Quality Tools across the Business Unit, including 8D Corrective Action, Error Proofing, Failure Modes and Effects Analysis (FMEA), Design for Manufacturability (DFM), Statistical Process Control (SPC), Design Validation and Process Validation testing (DVT/PVT), and Critical to Quality (CTQ) documentation.
• Impacts product quality for assigned products, working with Site Quality and Product Support teams affecting warranty costs, instrument installations, and customer allegiance.
• Has the necessary independence and authority within the area, and through reporting relationships to initiate actions as needed to ensure the quality, safety and efficacy of all products.

Other miscellaneous duties as assigned.

Minimum Requirements/Qualifications:

• Bachelor’s degree in engineering or related scientific discipline; MBA or advanced engineering or scientific degree is preferred.
• Minimum 10 years’ experience in Quality Assurance management and leadership, preferably in Medical Device environment.
• Minimum 3 years in a Quality Leadership Role in a medical device company or other highly regulated industry such as aerospace or automotive. Experience in a startup environment is a plus.
• Strong project leadership capability and ability to drive culture change. Working knowledge of ISO requirements. Experience working in a six sigma or TQM manufacturing environment.
• Proven experience in using data and statistical techniques to drive continuous improvements.
• Extensive knowledge and experience in validation process design and process validation, change control, and auditing quality management systems.
• Experience working with a broad range of people from manufacturing personnel to senior management.
• Experience in product development software and hardware quality systems and audits.

Compensation and Benefits

The salary range estimated for this position based in California is $112,500.00–$150,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards