6 дней назад
Quality Control Inspector (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Control Inspector (Medical Devices): Performing incoming, in-process, final, stock verification, and first article inspections for regulated medical device manufacturing with an accent on inspection accuracy, quality documentation, and product conformity. Focus on training inspectors, supporting NPI and validation activities, resolving nonconforming materials, and coordinating supplier quality issues.
Location: Vista, California, United States; onsite role
Company
is a medical technology company developing clinically differentiated orthopedic products, services, and integrated technologies.
What you will do
- Perform incoming, in-process, final, and stock verification inspections according to procedures, specifications, and sampling plans.
- Train, coach, and onboard Quality Control Inspectors while providing technical guidance on inspection methods and acceptance criteria.
- Execute and document First Article Inspections and support validation, verification, and qualification activities.
- Collaborate with Quality Engineering, Operations, Manufacturing, and Supply Chain teams on NPI and product transfers.
- Coordinate nonconforming material activities, including identification, segregation, documentation, and disposition routing.
- Maintain compliant inspection reports, quality records, and supporting documentation.
Requirements
- High school diploma or equivalent required; a related technical discipline is preferred.
- At least 5 years of Quality Control, Inspection, Quality Assurance, or Manufacturing Quality experience in a regulated manufacturing environment; medical device experience is preferred.
- Working knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, and applicable quality system regulations.
- Experience with incoming, in-process, final, and first article inspections, engineering drawings, specifications, bills of materials, and GD&T.
- Proficiency with precision measurement tools such as calipers, micrometers, height gauges, comparators, and pin gauges.
- Applicants must already have full-time work authorization in the United States and must not require employment visa sponsorship now or in the future.
Nice to have
- Experience in medical device manufacturing.
- Experience with ERP and electronic quality management systems such as Oracle, SAP, Agile, NetSuite, ETQ, or MasterControl.
Culture & Benefits
- Collaborative environment focused on continuous improvement and scientific excellence.
- Medical, dental, and vision insurance.
- Spending and savings accounts and a 401(k) plan.
- Vacation, sick leave, holidays, income protection plans, discounted insurance rates, and legal services.
- Physical requirements include extended periods of sitting and standing and lifting or carrying up to 25 pounds.
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