Quality Engineer III at Thermo Fisher Scientific

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAs part of the Thermo Fisher Scientific team youll 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 needed to achieve their individual career goals while helping advance science by developing solutions to some of the worlds toughest challenges.Location/Division Information:Santa Claras CA. Relocation assistance is NOT provided.*Must be legally authorized to work in the United States withoutsponsorship.*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 cybersecurityDrive 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:EducationA bachelors degree in Engineering or a Science-related field is required.Experience5 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 AbilitiesISO 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 increasesExcellent BenefitsBenefits & Total Rewards Thermo Fisher ScientificMedical Dental & Vision benefits - Effective Day 1!Paid Time Off & Paid HolidaysRetirement Savings PlanTuition ReimbursementEmployee Referral BonusCompensation and BenefitsThe salary range estimated for this position based in California is $90900.00$136350.00.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 programsEmployee assistance and family support programs including commuter benefits and tuition reimbursementAt 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 policyRetirement and savings programs such as our competitive 401(k) U.S. retirement savings planEmployees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discountFor more information on our benefits please visit: Key Skills APQP,Quality Assurance,Six Sigma,ISO 9001,PPAP,Minitab,Root cause Analysis,ISO 13485,Quality Systems,Quality Management,As9100,Manufacturing Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 90900 - 136350