Staff Quality Assurance Engineer

Work Schedule

Environmental Conditions

Job Description

Position Title: Staff Quality Engineer

When youre part of the team at Thermo Fisher Scientific youll do important work. And youll 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 withoutsponsorship.

*Must be able to pass a comprehensive background check whichincludes 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: Bachelors degree in Engineering or a related technical or scientific field required
• Masters degree preferred.
• ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt strongly preferred.

Experience:

• 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.

Knowledge Skills & Abilities

• 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.

Physical Requirements

• 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 100000 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

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: Experience:

Staff IC