Senior Manufacturing Quality Engineer

Saint Paul
Sep 06, 2017
Oct 06, 2017
Ware Technology Services
Job Type
Employment Status
Full Time
We are working with a contract manufacturer located in St. Paul that is need of a Sr. Manufacturing/Quality Engineer. This is a 6 month contract with high potential for permanent hire. The ideal candidate will have a Bachelor's in a related Engineering field, have 8+ years experience in the medical device industry, be familiar with ISO and FDA regulations, and have electronics knowledge.

Key Responsibilities:
- Support the transfer of products from design to manufacturing and participates on production teams to support the manufacturing of complex electronic and software based medical devices.
- Support the quality system maintenance, corporate quality initiatives, improvement activities, and customer quality relationship for assigned manufacturing lines.
- For design transfer projects, this role will own and support design transfer deliverables, including development of appropriate process control and inspection methodologies.
- For production released products, this role will manage quality control strategies, disposition processes, continuous improvement initiatives, and change management.
- Participate in customer meetings during ongoing product reviews.
- Perform process FMEA's and qualifications.
- Review drawings and specifications for completeness of requirements to establish inspection requirements.
- Support the customer complaint investigation and CAPA root-cause investigation processes.
- Support the supplier management process including selection, approval and problem resolution to ensure parts and components delivered meet specifications.
- Participate in the identification and maintenance of appropriate metrics to assess the effectiveness of the manufacturing processes and the quality system.
- Develop inspection/test fixtures and equipment to support receiving and final inspection.

- Bachelor's degree in an engineering, technical or scientific discipline required.
- 6-10 years of job experience performing quality engineering support for manufacturing electro-mechanical and software-based medical devices is preferred.
- Experience in design to product transfer activities including engineering change orders, specification/drawing reviews, qualifications and process FMEAs.
- A solid understanding of ISO 13485:2003 and the FDA Quality System Regulation in a manufacturing environment is a plus.
- Experience working with Product Development Core Teams and suppliers to implement consistent quality processes and set high benchmarks for new products from development through production.

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