Quality Engineer - Product Team...
| Department: | Quality |
| Location: | Minneapolis HQ |
| Apply Until: | 12/15/2009 |
| Office Hours: | 8:30 am - 5:00 pm |
| Division: | Minnesota Rubber and Plastics - Minneapolis HQ |
1. Facilitates the creation of validation plans, control plans, failure mode effect and analysis and process flow diagrams with cross-functional team members during project/program launch. Performs design of experiments and statistical process control as required to facilitate process improvement.
2. Participates as a cross-functional team member in project/program reviews, tool/process reviews, manufacturing reviews, and lessons learned reviews in support of the project/program launch process.
3. Completes follow-up with suppliers on open issues related to audit findings or supplier corrective actions.
4. Performs applicable quality system audits and follow-up activity with suppliers and potential suppliers as deemed appropriate by the cross-functional project/program launch team.
5. Designs, develops and purchases inspection fixtures, go / no-go gauges and other forms of inspection gauging.
6. Performs other duties and assumes accountabilities as apparent or as delegated, including mutually agreed upon objectives.
Relationship to others:
This role will work directly with corporate and plant engineering to support the project/program launch process. In addition, being a direct contact with suppliers, purchasing and plant quality on supplier quality issues.
Dimensions of Position:
This position does not directly supervise, but has the general freedom to interface with virtually every department or function within the organization as the need exists. Developed interpersonal and communication skills are necessary. Travel may be required up to 15% of the time annually, including international travel.
Education: Bachelors degree in Engineering or related field, or equivalent experience required.
Experience: Eng I (0-1 yr.), Eng II (1-3 yr.), Eng III (3-6 yr.), Senior Eng (6+ yr and possible additional accountabilities)
* Experience in quality and/or metrology in a medical device manufacturing environment required.
* Experience with industrial and medical product development activities.
* Proficient with the use of process failure mode effect and analysis.
* Strong knowledge of FDA and quality standards (21CFR 820, ISO13485 & TS16949).
* Exposure to nondisclosure agreements and 510k submissions.
* Training and knowledge of statistical analysis/techniques.
* Proficient use of Microsoft Excel, Word and Powerpoint.
For Further Information Contact:
Pete Peterson, VP Human Resources
Minnesota Rubber and Plastics
1100 Xenium Lane North
Plymouth, MN 55441
952-927-1400
humanresources@mnrubber.com
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Equal Opportunity Employer