Senior Manufacturing Quality Engineer

Location
Saint Paul
Posted
Sep 06, 2017
Closes
Oct 06, 2017
Ref
298654
Contact
Ware Technology Services
Job Type
Employee
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.

Qualifications:
- 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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