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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day, enabling our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources they need to achieve their individual career goals while advancing science by developing solutions to some of the world’s toughest challenges.

Location/Division Information:

Santa Clara, CA. Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States without sponsorship.

*Must be able to pass a comprehensive background check, which includes a drug screen.

Discover Impactful Work:

This role requires a hands-on professional with a strong background in quality assurance. The ideal candidate will have a firm grasp of ISO and FDA regulations and the ability to lead investigations and continuous improvement initiatives across both development and production environments. This role involves frequent cross-site collaboration with our internal contract manufacturing sites in Lithuania and Singapore, which may lead to early or late meetings.

A Day in the Life:

+ Primary QA support for a brand-new flagship Microarray instrument system launching in early 2026.

+ Working collaboratively with Global Technical Operations, Global Product Support, Manufacturing Operations, Product Legislation Compliance, and Regulatory Affairs.

+ Support Customer Feedback/Complaint Handling and CAPA investigation processes.

+ Lead investigations into complaints and OEM partner requests regarding software cybersecurity

+ Drive on-market change control activities, including leading Risk and Impact Assessments.

+ Perform audits of critical internal contract manufacturers. Front room participation in annual Notified Body audits (ISO13485, MDSAP, and IVDR).

+ Drive product and process changes to improve product quality.

Keys to Success:

Education

+ A bachelor’s degree in Engineering or a Science-related field is required.

Experience

+ 5+ years of experience in an Engineering, Quality, or Regulatory capacity (preferably within the medical device, biotech, or pharmaceutical sector) required.

+ ISO 13485:2016 and 21CFR820 (FDA QMSR) knowledge required, Regulation (EU) 2017/746 (EU IVDR), and 21CFR820 (FDA QMSR) knowledge preferred.

+ Lead auditor experience preferred.

Knowledge, Skills, Abilities

+ ISO 14971: 2019 risk management compliance.

+ Strong analytical and problem-solving skills.

+ Proficient with Microsoft Office tools: Word, Excel, Visio, Teams.

+ Excellent interpersonal, organizational, and influencing skills.

+ Proven knowledge of Quality Management System tools and continuous improvement methodologies.

What We Offer:

+ Annual performance-based bonuses and merit increases

Excellent Benefits

+ Benefits & Total Rewards | Thermo Fisher Scientific

+ Medical, Dental, & Vision benefits - Effective Day 1!

+ Paid Time Off & Paid Holidays

+ Retirement Savings Plan

+ Tuition Reimbursement

+ Employee Referral Bonus

Compensation and Benefits

The salary range estimated for this position based in California is $90,900.00–$136,350.00.

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.