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Thermo Fisher Scientific · 1 month ago

Staff Quality Assurance Engineer

Santa Clara, CA

Full-time

Onsite

Senior Level, Lead/Staff

$112K/yr - $169K/yr

8+ years exp

Thermo Fisher Scientific is a leading company in the biotechnology and biopharmaceutical sector, providing innovative solutions for drug development and manufacturing. The Staff Quality Engineer will be responsible for maintaining quality standards and regulatory compliance, partnering with various teams to ensure high-quality bioprocessing equipment and products through effective quality management systems.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

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

Qualification

CGMPISO 13485ISO 9001ISO 14971Quality Management SystemsCAPA managementRoot Cause AnalysisStatistical AnalysisSix SigmaQuality AssuranceMS OfficeLeadershipProblem SolvingCommunication Skills

Required

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

Minimum required Education: Bachelor's degree in Engineering or a related technical or scientific field required

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

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

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%

Preferred

Master's degree preferred

ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt strongly preferred

Advanced statistical analysis experience (e.g., reliability, sampling plans, MSA) preferred

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

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