Description
QUALIFICATIONS:- Bachelors Degree
- Minimum 2 years experience
- Medical Device industry experience preferred
RESPONSIBILITIES:
- Designs gages and fixtures to improve and simplify inspection of products. Conducts gage design reviews with Tooling Team personnel and interfaces with Sourcing personnel, suppliers, and outside gauging suppliers as needed.
- Performs Quality Planning Design reviews for new products and launches
- Depositions nonconforming product. Processes associated nonconformance reports (MCDRs), deviation requests (ERBs) and CAPA requests (CARs) accordingly.
- Develops IQS criteria and insures that features are properly identified and in agreement with engineering drawings. Approves and initiates associated change requests as required (Memo to File, Engineering Change Order).
- Optimizes inspection criteria to improve quality throughout manufacturing and at final inspection while insuring product functionality.
- Reviews QC work histories to identify products requiring high inspection times and rejections and reviews so changes to processes or specifications can be identified and improvements made to increase quality and throughput
- Performs technical quality reviews of suppliers to support purchasing personnel certifying suppliers.
- Makes recommendations for upgrades, acquisitions and enhancements related to equipment and software to support and improve the quality system.
- Travels as required for company business
- Performs supplier audits and source inspection activities as required.
- Supports supplier approval process as required.
- Utilize PFMEA tools to perform process improvements