SQAFYI - Software QA Resource - FYI

US-IN-Warsaw: Quality Engineer

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 03-Jul-2008

Quality Engineer

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 gauging 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. Critical to Quality characteristic identification.

3. Depositions nonconforming product. 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. Trains 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 gaging 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.

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

18. Supports supplier approval process as required.

19. Performs other duties as needed.

Basic Qualifications

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 2 years of experience.

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

PROFESSIONAL SKILLS AND PERSONAL ATTRIBUTES:

1. Works well in a fast paced environment.

2. Organized and able to attain results on several projects simultaneously.

3. Ability to transfer technical expertise by teaching, developing and mentoring employees and supplier personnel.

4. Values others’ ideas and experienced working in a team environment.

5. Ability to work well with a diverse group of people.

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

7. Knowledgeable in the current state of the art quality systems, gaging methods and equipment.

8. Results-oriented.

9. Self-starter.

10. Good oral and written communication skills.

For more information, please write to us.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com

US-IN-Warsaw: Quality Engineer