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Manufacturing Quality Engineer
On-siteFull-timeManufacturing Quality ManagementMedical Devices
Onsite opportunity for a Manufacturing Quality Engineer to oversee quality activities at a manufacturing subcontractor, support validation and product transfer, and improve regulated medical device production processes.
Responsibilities
- Own quality activities at an assigned manufacturing subcontractor
- Provide quality oversight for validation, pilot processes, product transfer, and production activities
- Write, review, and approve pilot documents, procedures, reports, and production forms
- Lead investigations into production deviations and nonconformities and prepare analysis reports
- Train subcontractor personnel on quality assurance procedures and requirements
- Support sorting, rework, and other special production processes
- Ensure manufacturing follows company procedures and GMP/GDP standards
- Stop and restart production in accordance with quality requirements and management approval
- Lead production-related projects, including data integrity, cost-of-poor-quality, and process improvement initiatives
- Manage audits, production and machine projects, and subcontractor quality interfaces
- Serve as the quality focal point in pilot and cross-functional project meetings
Requirements
- Bachelor’s degree in engineering or a science-related field; relevant experience may substitute for the degree
- At least 3 years of quality engineering experience in a regulated industry, pharmaceutical manufacturing, or medical device manufacturing
- At least 3 years of experience across the medical device quality and production lifecycle
- Ability to work independently, manage multiple activities, and collaborate effectively in a fast-paced environment
Nice to have
- Experience with production processes and process controls
- Experience working with manufacturing subcontractors and customer expectations
- Experience with medical devices, validation, risk management, and product transfer
- Knowledge of ISO 13485, 21 CFR 820, ISO 14971, or MDSAP
- Root cause and failure analysis experience
Benefits
- Benefits supporting physical, mental, emotional, and financial well-being
- Learning, growth, and development opportunities
- Inclusive workplace and community support initiatives
- Sustainability-focused work environment