Description
POSITION 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 which may include preparation of PFMEAs, Control Plans, Criteria development, and Critical to Quality characteristic identification.
- 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.
- Trains Medtronic employees and supplier personnel in specific product requirements and Quality tools and techniques.
- Tracks and Trends Quality Data; reviews QC work history to optimize inspection throughput. Generates CAPA requests as required to address systemic problems ascertained via data analysis.
- Develops SPC and associated data collection methods.
- Recommends and implements improved gauging methods for in-process and final inspection operations.
- Responsible for maintaining standardizing and optimizing product inspection procedures.
- Specifies and requisitions measuring and gaging equipment as required.
- Makes appropriate changes in Gauging and inspection procedures when dictated by engineering drawing changes. Documents all changes through the appropriate control system.
- Resolves technical production problems on assigned product lines involving gauging and inspection procedures working with shop employees and suppliers and other team personnel.
- 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 which could be extensive at times. May include visits to supplier facilities, visits to Memphis for meetings, visits to other Medtronic facilities, and travel to training classes or seminars.
- Performs supplier audits and source inspection activities as required.
- Supports supplier approval process as required.
- Utilize PFMEA tools to perform process improvements
- Performs other duties as needed.
- Adhere to the Medtronic Traits of: Mission Values, Compliance & Integrity, External Focus, Clear Thinking, Driven to Win, Inspires Others, Executes, Boundaryless, Global.
QUALIFICATIONS:
- Bachelors Degree, Masters Degree preferred
- Minimum 2 years experience providing direct manufacturing process support in a high tech manufacturing environment, or 5 years of direct quality experience.
- Medical Device industry experience preferred
- ASQ-CQE Certification preferred
- Formal Project Management training
- Minitab, Statistical Process Control software application experience
- Masters degree with less than 2 years of experience