Supplier Quality Engineer
Pittsburgh, Pennsylvania | Contract
Supplier Quality Engineer (SQE Engineer)
We have an opportunity with our client in Pittsburgh, PA for a Supplier Quality Engineer.
This position is responsible for the development, documentation, and management of Supplier Quality Assurance and Control processes as required to support company quality objectives. This position will act as the Supplier quality consultant to transfer project teams, and will lead projects to resolve supplier quality issues.
Requirements of the Supplier Quality Engineer
- Bachelor’s Degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc)
- 5-7 years’ experience in the manufacture of Electro-Mechanical devices
- 3-5 years’ experience in FDA regulated Medical Device Manufacturing
- Solid understanding of the FDA QSR and/or ISO 9000/ISO 13485 Quality System Requirements
- Strong knowledge of inspection/sampling techniques and familiarity with ANSI/ASQ Zl .4
- Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)
- Excellent oral and written communication skills
- Ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and component qualifications.
- Strong familiarity with mechanical and physical inspection techniques (calipers, micrometers, depth gauges, blueprint reading, optical comparator, etc.)
- Strong project planning skills and a strong focus on meeting customer needs.
Desired Skills and Qualifications
- ASQ Certified Quality Engineer, ASQ Certified Quality Auditor, or equivalent.
- Familiarity with IS014971 and associated Risk Management Processes
- Familiarity with automated and semi-automated inspection equipment such as Coordinate Measurement Systems
- Ability to work with and motivate people.
- Proven leadership skills in a fast pace environment.
Supplier Quality Engineer (SQE Engineer) - 14426