Work ScheduleStandard Office Hours (40/wk)
Environmental ConditionsOffice
Job DescriptionLocation: On-site Santa Clara, CA. 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 You Will Make an Impact:The Quality Engineer III provides quality engineering support for bioprocessing equipment automation products, manufacturing and quality systems, ensuring products and processes consistently meet customer, regulatory, and business requirements. This role drives business performance by leading quality investigations, managing quality system processes, reducing risk, and implementing continuous improvement initiatives that enhance product quality, compliance, and operational efficiency. The position ensures compliance with GMP, ISO, and applicable regulatory standards while maintaining ownership of site quality processes and supporting audit readiness across the business.
Day In The Life:Quality Systems Management- Lead and manage CAPA, deviation, nonconformance, and change control activities.
- Review quality records to ensure timely investigation, root cause determination, and effective corrective actions.
- Facilitate and document risk assessments using FMEA and other risk management methodologies.
- Ensure compliance with document control and quality system requirements.
- Monitor quality system metrics and support continuous improvement initiatives.
Investigation & Compliance Support- Lead investigations related to product, process, supplier, and customer quality issues.
- Perform root cause analysis using structured problem-solving methodologies.
- Support validation and qualification activities to ensure compliance with quality and regulatory requirements.
- Participate in internal audits, customer audits, and regulatory inspections.
- Support supplier quality activities including qualification, issue resolution, and corrective action effectiveness reviews.
- Assist in the development and implementation of corrective and preventive actions.
Continuous Improvement & Risk Management- Analyze quality data and trends to identify improvement opportunities.
- Lead or participate in continuous improvement projects to enhance product quality and process performance.
- Evaluate quality risks associated with products, processes, and changes.
- Support implementation of preventive quality strategies and best practices.
- Drive initiatives that improve compliance, efficiency, and customer satisfaction.
Cross-Functional Collaboration & Customer Support- Partner with Manufacturing, Engineering, Validation, Supply Chain, and Regulatory Affairs teams to resolve quality issues.
- Provide quality guidance and support for equipment, automation system, process, and product changes throughout the product lifecycle.
- Support customer inquiries, complaint investigations, and supplier quality activities.
- Communicate quality risks, trends, and recommendations to stakeholders.
- Promote a culture of quality, compliance, and continuous improvement across the organization.
- Perform other duties and responsibilities as assigned to support business objectives, quality initiatives, and operational requirements.
Education & Experience:Required:- Advanced degree in Engineering, Life Sciences, Biotechnology or related field with 3 years of experience in quality assurance, quality engineering, or quality systems within a regulated industry such as biotechnology, pharmaceutical, medical device, life sciences, or related manufacturing environments OR Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology or related field with 5 years of experience in quality assurance, quality engineering, or quality systems within a regulated industry such as biotechnology, pharmaceutical, medical device, life sciences, or related manufacturing environments.
- Experience managing CAPA, deviations, nonconformances, change controls, and quality investigations.
- Experience conducting root cause analysis and implementing corrective and preventive actions.
- Experience supporting GMP and/or ISO-compliant quality management systems.
- Experience working cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams.
Preferred:- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality certification.
- Formal training in GMP, ISO 9001, ISO 13485, risk management, or quality systems.
- Experience within bioprocessing, automation systems, single-use technologies, life sciences equipment, or related regulated manufacturing environments.
- Experience supporting customer audits, regulatory inspections, and supplier quality activities.
- Experience with validation and qualification protocols.
- Experience leading continuous improvement and risk management initiatives.
- Experience utilizing electronic quality management systems (eQMS).
Knowledge, Skills, Abilities:Required:- Strong knowledge of GMP, GDP, ISO 9001, and applicable regulatory requirements; familiarity with ISO 13485 is preferred.
- Expertise in quality systems including CAPA, deviation management, change control, document control, and risk management.
- Strong understanding of root cause analysis methodologies and problem-solving tools.
- Knowledge of validation, qualification, and quality risk management principles.
- Ability to conduct risk assessments using FMEA and related methodologies.
- Strong analytical skills with the ability to interpret quality data, identify trends, and recommend improvements.
- Excellent written and verbal communication skills for interaction with internal stakeholders, customers, auditors, and regulatory agencies.
- Strong project management and organizational skills with the ability to manage multiple priorities.
- Ability to work independently while collaborating effectively within cross-functional teams.
- Proficiency with Microsoft Office applications including Excel, Word, PowerPoint, and data analysis tools.
- Experience using electronic Quality Management Systems (eQMS) such as TrackWise, MasterControl, or equivalent.
- Strong attention to detail while maintaining a broad business perspective.
Preferred:- Knowledge of bioprocessing equipment, automation systems, and single-use technology products.
- Experience with statistical analysis techniques and quality tools.
- Familiarity with ERP systems such as SAP.
- Experience with data visualization and reporting tools such as Power BI.
- Additional language proficiency to support global customer and supplier interactions.
- Physical Requirements and Work Environment:
- Combination of office-based work and manufacturing floor activities within a regulated production environment.
- Frequent sitting for documentation review, data analysis, investigations, and quality system management activities.
- Regular walking and standing throughout manufacturing, warehouse, laboratory, and engineering areas to support investigations, audits, and quality oversight activities.
- Occasional bending, reaching, and light physical movement required during inspections, audits, and process observations.
- Occasional lifting of materials or equipment up to 25 lbs with appropriate assistance when required.
- Ability to conduct extended audits, investigations, and facility walkthroughs across manufacturing and engineering areas.
- Exposure to manufacturing equipment, production operations, and moderate noise levels.
- Use of required PPE including safety glasses, gloves, protective footwear, gowns, or other site-specific protective equipment when entering controlled manufacturing areas.
- Regular interaction within GMP and ISO-regulated environments requiring strict adherence to quality and safety procedures.
- May require participation in audits, customer visits, and cross-functional activities across the site.
- Ability to travel up to 25% domestically and internationally as business needs require.
Compensation and BenefitsThe salary range estimated for this position based in California is $91,000.00-$130,000.00.
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
