Quality Assurance Engineer

Work Schedule

Standard (Mon-Fri)

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 heights

Position Title:
Staff Quality Engineer

When 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.

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.

The Bio Production 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.

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:

• 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.

• 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…