Quality Engineer III
$40 - $45 per hourExperis/Manpower Group
Our client, a leader in the bioprocessing equipment manufacturing industry, is seeking two dedicated and detail-oriented Quality Engineer III's to join their dynamic team. As a Quality Engineer III, you will be an integral part of the Quality department supporting manufacturing, integration, and testing activities. The ideal candidate will demonstrate strong problem-solving skills, excellent communication, and a proactive approach to quality assurance, aligning seamlessly with the organization's commitment to excellence and continuous improvement.
Job Title: Quality Engineer III (2 openings) Location: Santa Clara, CA Pay Range: $40-45/hr. Job Type: 12-month contract with the potential for hire/extension Schedule: M-F 40 hrs./wk. What's the Job?- Serve as the primary Quality Engineering partner for manufacturing, integration, and test activities supporting engineered-to-order bioprocessing equipment and automation systems.
- Collaborate with Manufacturing, Engineering, Automation, Project Management, and Supply Chain teams 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, including review of build records, test documentation, and release packages, and perform or support IQ, OQ, PQ activities.
- Develop, maintain, and approve SOPs, work instructions, templates, and quality records in compliance with cGMP, ISO 9001, and ISO 13485 standards.
- Bachelor of Science degree in Mechanical, Process, Electrical, Automation, Biomedical Engineering, or a related technical field.
- 4+ years of experience in Quality Engineering or a related technical role within a regulated manufacturing environment.
- Hands-on experience supporting engineered-to-order bioprocessing or capital equipment, including mechanical assembly, electrical/automation integration, and testing activities.
- Strong knowledge of cGMP principles and quality standards such as ISO 9001, ISO 13485, ISO 14971, and ISO 17025.
- Proficiency with site Quality Management Systems, including Document Control, CAPA, Deviations, Nonconformance, Change Management, and Auditing.
- Opportunity to work in a cutting-edge manufacturing environment supporting innovative bioprocessing solutions.
- Engage in meaningful projects that impact global health and biomanufacturing advancements.
- Collaborate with a diverse and talented team committed to quality and continuous improvement.
- Develop your skills through exposure to industry standards and regulatory compliance processes.
- Be part of a company that values integrity, accountability, and professional growth.
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account
- Health Flexible Spending Account
- Dependent Care Flexible Spending Account
- Supplemental Life Insurance
- Short Term and Long Term Disability Insurance
- Business Travel Insurance
- 401(k), Plus Match
- Weekly Pay
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