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Manufacturing Quality Engineer
В офисеПолная занятостьManufacturing Quality ManagementMedical Devices
Onsite manufacturing quality role responsible for subcontractor production oversight, validation, product transfer, quality investigations, and process improvement in medical device manufacturing.
Обязанности
- Own manufacturing quality activities at an assigned subcontractor and ensure production follows company procedures and GMP/GDP standards
- Provide quality oversight for validation activities, pilot processes, production transfers, and engineering work
- Lead investigations into production deviations and nonconformities and prepare analysis reports
- Write, review, and approve pilot reports, procedures, protocols, and production forms
- Train subcontractors on quality assurance procedures and related requirements
- Support sorting, rework, and other special production processes
- Manage production-related projects involving data integrity, cost of poor quality, and production improvement plans
- Serve as the quality focal point for internal, external, and production pilot meetings
- Approve quality aspects of pilot protocols and reports and ensure compliance with approved guidance
- Stop and restart production in accordance with company requirements and management approval
- Identify and implement improvements to products, services, processes, and production controls
- Work cross-functionally to guide projects and maintain required product and quality standards
Требования
- B.Sc. in engineering or science; relevant work history may substitute for the degree
- At least 3 years of experience in medical device quality and production lifecycle activities
- Experience with production processes, process controls, subcontractor interfaces, and customer expectations
- Experience with medical device validation, risk management, and product transfer to production
- Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, and MDSAP quality systems
- Knowledge of root-cause failure analysis and deviation or nonconformity investigations
- Effective problem-solving, communication, interpersonal, organizational, and multitasking skills
Будет плюсом
- Experience in medical device or pharmaceutical manufacturing
- Experience with MasterControl, SharePoint, or Teamcenter
- Certified auditor qualification
Условия и преимущества
- Benefits supporting employees and their families
- Learning, growth, and development opportunities
- Inclusive workplace and community initiatives