Quality Engineer III

Job Title: Quality Engineer III Job Description
The Quality Engineer III provides manufacturing and project quality support for engineered-to-order bioprocessing equipment and automation systems. This role serves as the primary Quality Engineering partner for manufacturing, integration, and test activities, ensuring that quality requirements are met throughout build, integration, FAT, and release. The Quality Engineer III develops and maintains quality systems and documentation in alignment with cGMP and ISO 9001 standards, leads investigations and risk management activities, and drives continuous improvement through data-driven quality metrics. The role also provides leadership and mentorship to site quality personnel while promoting a strong culture of quality, accountability, and continuous improvement.
Responsibilities
- Serve as the primary Quality Engineering partner for manufacturing, integration, and test activities supporting engineered-to-order bioprocessing equipment and automation systems.
- Partner with Manufacturing, Manufacturing Engineering, Automation, Project Management, and Supply Chain to ensure quality requirements are met throughout project execution, including build, integration, FAT, and release.
- Provide hands-on quality support on the production floor, addressing real-time quality issues related to equipment assembly, wiring, tubing, automation configuration, testing, and documentation.
- Support quality readiness for HAT/FAT and customer acceptance activities by reviewing build records, test documentation, and release packages, and performing or supporting IQ, OQ, and PQ activities.
- Develop, maintain, and approve SOPs, work instructions, templates, and quality records supporting manufacturing, integration, inspection, and release activities in compliance with cGMP, ISO 9001, and applicable ISO requirements.
- Ensure effective implementation and compliance with site Quality Management System processes, including Document Control, Training, Deviations, CAPA, Change Management, and Nonconformance.
- Serve as the Quality representative for New Product Introduction, project customization, and Engineering Change Orders, ensuring quality and compliance impacts are assessed and mitigated.
- Review and approve quality-related documentation associated with equipment builds, including inspection records, deviation reports, nonconformance records, CAPAs, and change documentation.
- Lead complex deviation, nonconformance, CAPA, and customer complaint investigations related to product performance, functionality, supplier issues, or documentation gaps.
- Apply structured Root Cause Analysis and risk management tools, such as RCCM, FMEA, fault tree analysis, 5 Whys, and Fishbone diagrams, to identify systemic issues and drive effective corrective and preventive actions.
- Lead MRB activities, including disposition of nonconforming components, subassemblies, and systems, and issuance of CAPA or SCARs as appropriate.
- Own product ship holds for potential product escapes, including initiation, containment, cross-functional communication, risk assessment, and resolution.
- Support customer-facing quality actions, including field corrections, retrofit activities, and recall-related assessments when applicable.
- Partner with Supplier Quality, Procurement, and Engineering to address supplier quality issues, including review and disposition of supplier nonconformances and SCARs.
- Review and approve ECOs, deviations, configuration changes, and automation or software updates for quality, compliance, and customer impact prior to implementation.
- Ensure changes affecting design, materials, assembly processes, testing, or documentation are properly assessed, implemented, and verified.
- Establish, monitor, and analyze site-level quality KPIs, including trends in deviations, CAPAs, nonconformances, supplier issues, and customer complaints.
- Use data and statistical analysis to identify quality risks, prioritize improvement opportunities, and drive corrective actions.
- Lead or actively participate in PPI, RCCM, and other continuous improvement initiatives to improve right-first-time yield, reduce rework, and enhance product quality and reliability.
- Lead or support internal audits in alignment with corporate and site quality system requirements, applicable ISO 9001 standards, and cGMP requirements.
- Serve as a Subject Matter Expert during customer, certification, and regulatory audits, supporting audit preparation, execution, and response.
- Provide day-to-day leadership, coaching, and mentorship to Quality Engineers and Quality Technicians at the site.
- Act as a quality escalation point for complex or high-risk issues, exercising sound, risk-based judgment and influencing cross-functional decisions.
- Promote and reinforce a strong culture of quality, accountability, and continuous improvement across the site.
- Complete complaints and RMAs using structured root cause analysis and CAPA methodologies.
- Perform other duties as assigned to support evolving business needs at the manufacturing site.
Essential Skills
- Bachelor of Science degree in Mechanical, Process, Electrical, Automation, Biomedical Engineering, or a related technical field required.
- Masters degree in a related technical field preferred.
- 4+ years of experience in Quality Engineering or a related technical role within a regulated manufacturing environment.
- Demonstrated experience supporting engineered-to-order bioprocessing or capital equipment, including mechanical assembly, electrical or automation integration, and testing activities.
- Strong working knowledge of cGMP principles and quality standards, including ISO 9001 and applicable ISO standards.
- Hands-on experience with site Quality Management Systems, including Document Control, CAPA, Deviations, Nonconformance, Change Management, and Auditing.
- Experience working with ERP, PLM, MES, and electronic document control systems.
- Ability to interpret mechanical drawings, electrical schematics, bills of materials, design control documentation, and technical specifications.
- Proven ability to manage multiple complex, project-driven priorities with minimal supervision.
- Strong verbal and written communication skills, including technical documentation and customer-facing correspondence.
- Excellent analytical, problem-solving, and risk-based decision-making skills.
- Demonstrated ability to influence cross-functional teams and site leadership without direct authority.
- High attention to detail, strong organizational skills, and sound professional judgment.
- Proficiency in Microsoft Office, SharePoint, and Microsoft Teams.
- Ability to adapt to changing customer requirements, project schedules, and regulatory expectations in a fast-paced manufacturing environment.
- Experience with root cause analysis techniques such as 5 Whys, Fishbone diagrams, RCCM, and FMEA.
- Experience in managing CAPA processes, handling complaints, and completing RMAs.
Additional Skills & Qualifications
- Professional certifications such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or Six Sigma Green Belt or Black Belt are highly desirable.
- Experience leading MRB activities and managing SCARs with suppliers.
- Experience supporting HAT, FAT, IQ, OQ, and PQ activities for complex equipment.
- Familiarity with risk management tools, including fault tree analysis and other structured risk assessment methods.
- Experience serving as a Subject Matter Expert during customer, certification, or regulatory audits.
- Demonstrated experience driving continuous improvement initiatives to improve right-first-time yield and reduce rework.
- Comfort working in both office and manufacturing environments with cross-functional and project-based teams.
Work Environment
This role operates in both office and manufacturing environments within a fast-paced, project-driven setting. The position requires extended periods working at a computer as well as time on the production floor supporting assembly, integration, and testing activities. The role involves standing and walking for extended periods, lifting and carrying items up to 35 lbs, and climbing up and down ladders as needed to access equipment or work areas. Personal protective equipment is required when working in manufacturing and integration areas. The environment emphasizes strong adherence to cGMP, ISO 9001, and site Quality Management System requirements, with frequent interaction across Manufacturing, Engineering, Automation, Project Management, Supply Chain, and Quality teams. The culture promotes quality, accountability, collaboration, and continuous improvement, supported by modern digital tools such as ERP, PLM, MES, electronic document control systems, and collaboration platforms.
Job Type & Location
This is a Contract position based out of Santa Clara, CA.
Pay and Benefits
The pay range for this position is $40.00 - $45.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Santa Clara,CA.
Application Deadline
This position is anticipated to close on Oct 2, 2026. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
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