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Lead Quality Assurance Engineer
2 months ago
TOMZ Corporation is seeking a dedicated Senior Quality Assurance Engineer – Sustained Manufacturing to enhance our team. As a prominent player in the production of devices and components for leading medical device firms, TOMZ provides attractive compensation packages along with comprehensive benefits. These benefits include 401k plans, health/dental coverage, vision insurance, and paid time off. Our facility is modern, well-maintained, and prioritizes safety, equipped with cutting-edge technology and a commitment to ongoing process enhancement. TOMZ is recognized by the FDA as a Class 2 and Class 3 Medical Device Manufacturer and holds ISO 13485 certification.
POSITION OVERVIEW:
This role is pivotal in overseeing the Quality Assurance activities related to Sustained Manufacturing of commercial products and ensuring the effective transition of Development programs into standard production. The successful candidate will lead, mentor, and provide technical support to cross-functional Engineering teams. This position will also involve contributing to the formulation and execution of strategies aimed at improving the Quality System. The work environment is dynamic and fast-paced.
KEY RESPONSIBILITIES:
- Initiate and/or collaborate on the creation and/or revision of Risk Management FMEA documentation in partnership with cross-functional engineering teams based on project needs.
- Assist in the operational and process qualifications for customer manufacturing processes in collaboration with cross-functional engineering teams.
- Guide the implementation and ongoing enhancement of Incoming Inspection, First Article Inspection, In-Process, and Final Product Inspection plans.
- Ensure the continuous efficiency and enhancement of Test/Inspection Methods.
- Develop and validate suitable sampling plans, including the characterization of test/inspection methods and acceptance criteria.
- Utilize systematic problem-solving techniques to identify, prioritize, communicate, and resolve quality-related issues, including CAPAs, Complaints, and NCRs.
- Fulfill additional responsibilities as outlined in the comprehensive job description.
REQUIREMENTS:
Education:
· A minimum of a 4-Year degree or equivalent directly relevant industry experience (preferably in Engineering or Quality disciplines).
Experience:
· At least 7 years of experience in a regulated manufacturing setting.
