Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Working at heightsJob Description
Position Title: Staff Quality EngineerWhen you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Location: Santa Clara, CA., fully onsite - 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 screening.
How will you make an impact?
The BioProduction Group provides our biotechnology and biopharmaceutical customers with brand new single-use bioprocessing systems. These systems cover the entire bioproduction workflow and help develop and manufacture lifesaving vaccines and therapeutics.
What will you do?
The Staff Quality Engineer maintains alignment with internal quality guidelines and regulatory mandates, covering cGMP, ISO 9001, ISO 13485, and ISO 14971. This role partners with Manufacturing, R&D, and Supply Chain to provide high-quality bioprocessing equipment and automation products via dependable processes, defect reduction, and ongoing progress. Key responsibilities include:
Core Responsibilities- Lead complex investigations and root cause analyses (RCCA) on product defects, procedural issues, and customer complaints. Apply advanced problem-solving tools such as 8D, 5 Whys, Ishikawa, and statistical analysis.
- Drive effective CAPA and SCAR management: start, guide, monitor, resolve, and confirm actions to prevent recurrence and strengthen the QMS.
- Develop, implement, and maintain quality control systems, inspection protocols, and process controls aligned with GMP, GDP, ISO, and risk-management requirements.
- Establish and monitor key quality metrics and benchmarks; perform statistical trend analysis (SPC, DOE) and provide data-driven recommendations for product and process improvement.
- Lead or approve major quality work activities including investigations, CAPA reports, engineering change controls, deviations, validation documents, verification/validation protocols, and change control documentation.
- Provide leadership across Quality programs such as CAPA, Complaints, Build Control, Risk Management (FMEA), and Quality System optimization while offering domain expertise.
- Support building and development activities, including risk management per ISO 14971, DFMEA/PFMEA creation, and participation in NPI/phase-gate product development processes.
- Lead or support internal, external, and supplier audits; effectively represent Quality during regulatory, ISO, or customer audits.
- Lead significant quality system or process improvement projects using Lean, PPI, Kaizen, or DMAIC methodologies.
- Coordinate MRB processes, including disposition of nonconforming materials and determination of appropriate corrective actions.
- Lead product containment actions, including ship holds, internal communication, and customer notifications for product safety events, field corrections, or recall actions.
- Partner with team members to enhance risk assessments, improve processes and procedures, and drive proactive quality culture across the organization.
- Train and mentor diverse functional teams on quality principles, RCA tools, GMP compliance, and best-practice processes.
- Support field performance monitoring, service data analysis, and customer-facing investigations as needed.
- Perform other duties as required to support evolving business needs.
How Will You Get Here?
Education:- Minimum required Education: Bachelor’s degree in Engineering or a related technical or scientific field required
- Master’s degree preferred.
- ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt strongly preferred.
- Minimum 8 years of quality engineering experience in medical device, BioPharma equipment, or other regulated cGMP manufacturing environments.
- Strong understanding of cGMP, ISO 13485/9001/14971, and Build Control requirements.
- Experience with product development and NPI processes, including verification/validation, Build Control, PFMEA/DFMEA, and risk management.
- Experience supporting software validation, automation systems, or software-related quality processes.
- Hands-on experience with investigations, CAPA, audits, QMS processes, and leading quality efforts in a multi-functional environment.
- Experience in managing supplier quality, qualifying suppliers, and handling SCAR processes.
- Ability to interpret engineering drawings, BOMs, and technical specifications.
- Familiarity with ERP/PLM/QMS systems; experience with Agile PLM, Intuitive ERP, or UniPoint is a plus.
- Advanced statistical analysis experience (e.g., reliability, sampling plans, MSA) preferred.
- Proven ability to lead complex projects, prioritize multiple demands, and influence decisions across multi-functional teams with minimal supervision.
- Deep expertise in quality assurance, RCA methodologies, risk management, and corrective/preventive actions.
- Strong analytical and problem-solving abilities with data-driven decision-making.
- Strong verbal and written communication skills; able to explain complex ideas clearly.
- Strong leadership and influence abilities; capable of mentoring, coaching, and leading multi-functional teams.
- Highly organized, diligent, adaptable, and capable of growing in a fast-paced environment.
- Proficient in MS Office, SharePoint, Teams, Visio, Miro, and other tools that improve efficiency.
- Ability to adapt to new technologies, including software that uses artificial intelligence and digital quality systems.
- Capability to perform duties onsite in both office and manufacturing settings.
- Ability to lift up to 45 lbs occasionally.
- Capability to remain at a computer for prolonged durations (up to 8 hours/day).
- Must be able to travel up to 10%
What We Offer
Competitive Salary:
- Pay rate based on experience
- Annual performance-based bonus
- Annual merit performance-based increase
Excellent Benefits!
- Medical, Dental, & Vision benefits-effective Day 1
- Paid Time Off (120 hours per year) + Designated Paid Holidays
- 401K Company Match up to 6%
- Tuition Reimbursement – eligible after 90 days!
- Employee Referral Bonus
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Compensation and Benefits
The salary range estimated for this position based in California is $112,500.00–$168,670.00.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
Top Skills
What We Do
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Why Work With Us
You will join a company which every colleague has the opportunity to create possibilities, for oneself, for our customers and patients. There is no more exciting place to be than at the forefront of solving problems which help improve lives around the world. As a company, we are committed to supporting your career aspirations and your journey.
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