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Posted by: CHRIS INGALLS <cingalls@natleng.com> on October 07, 2009 at 07:06:16. Click here to reply to this post via Email.

Contract / Temp to Perm / Permanent: Permanent
City: KEENE
State: New Hampshire
Country: United States

***Experience in the medical device industry = MANDATORY

Job Title: Quality Engineering Manager
Location: Keene, New Hampshire
Category: Engineering - Manufacturing Experience: 6-9 years
Status: Full-Time

Position Description
The Quality Engineering Manager is responsible for ensuring compliance to internal and corporate procedures, appropriate FDA and international regulations and standards through design of robust quality systems. The QEM will support the development and transfer of new products from the design phase to production, and support enhancements to existing product lines.

Requirements
• Plan, conduct, and direct quality engineering studies encompassing projects for the design/development validation of new or modified products/processes.
• Quality systems development.
• Lead in the development of appropriate inspection methods and sampling plans.
• Ensure quality of data interpretation.
• Plan, conduct, and direct the application of quality technology, including but not limited to FMEA’s, DOE’s, QFD’s, SPC, and design control to projects, products, and processes.
• Review technical information for adherence to applicable regulatory requirements.
• Participate in cost reductions and profit improvement programs.
• Ensure compliance with company policies and business practices including FDA (Food & Drug Administration) regulations, GMP (Good Manufacturing Practices) and ISO (International Organization for Standardization) requirements.

Minimum Education and Experience
BS in Engineering or Applied Science.

Minimum Knowledge Abilities and Skills
• 5 – 10 years experience in Quality Control.
• Experience in the medical device industry MANDATORY.
• Minimum of 5 years previous supervisory experience, preferably in Quality Systems or Quality Assurance.
• Multi-disciplined Assurance background desirable.