Join a world leader in the medical technology industry. This firm has been recognized for eight of the last ten years by Fortune magazine as one of the “100 Best Companies to Work For”. The company’s mission statement - to alleviate pain, restore health, and extend life, is not just lip service, it is their daily goal.  Every 5 seconds the life of someone somewhere in the world is improved by the company’s product or therapy.  With this firm you not only work with the kind of people who love what they do but why they do it.

POSITION SUMMARY:  

Responsible for developing and maintaining systems for insuring Quality of products produced by manufacturing processes in machining, metal finishing, assembly, and outside supplier operations.

Initiates improvements in inspection methods to improve product quality, supplier performance
and to reduce manufacturing costs and lead time.

Position Responsibilities:

TYPICAL DUTIES/ACCOUNTABILITIES:
1. Designs gages and fixtures to improve and simplify inspection of products.  Conducts gage design reviews with Tooling Team personnel and interfaces with Purchasing personnel, suppliers, and outside gauge builders as needed.

2. Performs Quality Planning Design reviews for new products and launches which may include preparation of:
a. PFMEAs
b.  Control Plans
c.  Criteria development
d.  Quality characteristic identification.

3. Depositions nonconforming products.  Processes associated nonconformance reports (MCDRs), deviation requests (ERBs) and CAPA requests (CARs) accordingly.

4. Develops QC criteria and insures that features are properly identified and in agreement with engineering drawings.  Approves and initiates associated change requests as required (MTF, ECO).

5. Optimizes QC criteria to improve quality throughout manufacturing and at final inspection while insuring product functionality.

6. Train employees and supplier personnel in specific product requirements and Quality tools and techniques.

7. 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.

8. Develops SPC and associated data collection methods.

9. Recommends and implements improved gauging methods for in-process and final inspection operations.

10. Responsible for maintaining standardizing and optimizing product inspection procedures.

11.  Specifies and requisitions measuring and gauging equipment as required.

12. Makes appropriate changes in Gauging and inspection procedures when dictated by engineering drawing changes.  Documents all changes through the Manufacturing Engineering process control system.

13. Resolves technical production problems on assigned product lines involving gauging and inspection procedures working with shop employees and suppliers and other team personnel.

14. Performs technical quality reviews of suppliers for ship to stock certification.

15. Makes recommendations for upgrades, acquisitions and enhancements related to equipment and software to support and improve the quality system.

16. Travels as required for company business which could be extensive at times.  May include visits to supplier and company facilities, and travel to training classes or seminars.

17. Performs supplier audits and source inspection activities as required.

18. Supports supplier approval process as required.

QUALIFICATIONS:

EDUCATION AND EXPERIENCE:
1. Four-year Degree in Engineering discipline and at least 2 years of relevant experience in a high tech manufacturing environment providing direct manufacturing process support, or Masters degree with less than two years of experience.  

2. Medical device industry experience preferred along with ASQ-CQE Certification.  

PROFESSIONAL SKILLS AND PERSONAL ATTRIBUTES:
1. Ability to transfer technical expertise by teaching, developing and mentoring employees and supplier personnel.

2. Strong analytical and problem solving skills and experience applying these skills to resolve quality problems in a manufacturing environment.

3. Knowledgeable in the current state of the art quality systems, gauging methods and equipment.

Send a word resume to jthompson@tescareers.com

Thanks

Jeff Thompson-TES, Inc

440-266-0022 ext 104