Manufacturing Quality Engineer
On-siteQuality, California, United States
Job Summary
Own all production activities at a subcontractor to ensure manufacturing adheres to West procedures and GMP/GDP standards. Lead investigation processes for deviations and nonconformities, create analysis reports, and support special processes like sorting or rework. Write, review, and approve pilot documents, department procedures, and forms while providing quality oversight for validation activities and processes. Train subcontractors according to QA procedures and VoE, and manage production-related projects acting as the MQ focal point for internal and external initiatives including Data Integrity and production improvement plans. Responsible for stopping and renewing production with MQ manager approval. Lead pilot processes involving change and approval of quality aspects in protocols and reports.
Required Qualifications
- B.Sc. in Engineering or Science
- Minimum 3 years of experience in Medical Device Quality & Production lifecycle
- Experience with production processes and process controls
- Experience with sub contractors interface and meeting customer expectations
- Experience with Medical Device, Validation Activities, Risk Management, Product Transfer to production
- Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
- Must have effective problem solving and interpersonal skills
- Ability to work independently, multi-task and thrive in fast-paced environment
- Problem solving including root cause failure analysis methods
- Experience with Medical Device / Pharma
- Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events
- Must maintain the ability to work well with others in a variety of situations
- Maintain high attention to detail, accuracy, and overall quality of work
- Must be able to multi-task, work under time constraints, problem solve, and prioritize
- Observe and interpret situations, analyze and solve problems
- Effectively communicate and interface with various levels internally and with customers
- Must be able to lift 20lbs/9kg of force frequently
Desired Qualifications
- Previous experience with MasterControl, Share Point, Teamcenter
- Certified auditor
- Relevant work history and/or experience in lieu of degree
- Experience with Validation Activities, Risk Management, Product Transfer to production
- Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971, MDSAP
- Experience with Medical Device / Pharma - Advantage
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