Quality Lead

Job Summary:Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/ medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments.Key Responsi

Key ResponsibilitiesLead manufacturing quality assessments, audits, and continuous improvement initiatives.DriveFPY improvement, defect reduction, and manufacturing risk reduction.ReviewIQ/OQ/PQ process validations, TMV, SPC, MSA, and PFMEA.ManageCAPA, nonconformances, and supplier quality issues.SupportFDA, ISO 13485, MDSAP, and regulatory audits/inspections.Review manufacturing processes and quality metrics to identify improvement opportunities.Required SkillsManufacturing Quality Engineering

Kelly Science and Clinical FSP is currently seeking a Quality Engineer for a hybrid role in Irvine, California supporting our Medical Device client. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You will also be

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems