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Manufacturing Quality Engineer
במקום העבודהמשרה מלאהManufacturing Quality ManagementMedical Devices
Onsite manufacturing quality role responsible for subcontractor production oversight, validation, product transfer, quality investigations, and process improvement in medical device manufacturing.
תחומי אחריות
- 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
דרישות
- 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
יתרון
- Experience in medical device or pharmaceutical manufacturing
- Experience with MasterControl, SharePoint, or Teamcenter
- Certified auditor qualification
הטבות
- Benefits supporting employees and their families
- Learning, growth, and development opportunities
- Inclusive workplace and community initiatives