Thermo Fisher Scientific · 2 days ago
Staff Quality Assurance Engineer
Santa Clara, CA
Full-time
Onsite
Senior Level, Lead/Staff
$112K/yr - $169K/yr
8+ years expThermo Fisher Scientific is a leading company in biotechnology and biopharmaceuticals, providing innovative solutions to their customers. They are seeking a Staff Quality Assurance Engineer to ensure alignment with quality guidelines and regulatory mandates while partnering with various teams to enhance product quality and processes.
Research
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
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
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
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
Company data provided by crunchbase