Quality Assurance Manager

Profile

Experienced Quality leader and professional with a clear record of sustained success and corresponding progressive advancement in both QA/QC/QS and executive Site Operations over the past 25 years in the regulated medical device manufacturing industry. Prior Production management and Quality Assurance experience over several years in the high reliability aerospace electronics manufacturing industry.

Experience

Plant Manager, St. Jude Medical; Scottsdale, AZ 2005-Present

Provide leadership and operational oversight for site-wide operations and leaders of functional departments, including Engineering, Production, Continuous Improvement, Quality Systems and Quality Engineering. 440 employees producing high reliability medical device components in team-based, advanced technology environment. $35M annual operating expense; 500K various models produced.

Director of Quality Assurance, St. Jude Medical; Scottsdale, AZ 2002-2004

Responsible for leadership and functional oversight of all site quality systems operations, including Quality Engineering, Quality Assurance, Document Control, Metrology, Supplier Management and Quality Control Inspection.

Manager, Quality Assurance and Engineering, St. Jude Medical 1999-2002

Provided leadership and direct oversight of Quality Engineering, Quality Control, and related product acceptance operations.

Manager, Microelectronics Manufacturing, St. Jude Medical 1988-1998

Provided leadership in growing the microelectronics manufacturing business from small prototype capability to vertically integrated sole supply source of related products by developing teams which demonstrated cost, quality and partnership leadership vs. strong external competitors.

Education

Non-Degreed professional. Range of coursework in business management, industrial engineering and leadership development at Purdue University (West Lafayette), Indiana-Purdue University at Fort Wayne, West Coast University (Orange, CA) and Scottsdale Community College.

Skills

Well developed and practically applied organizational leadership skills utilized in regulated, advanced manufacturing environment. Demonstrated ability to provide quality leadership in a high performance work team structure. High fluency with rigorous quality system requirements (ISO 13485; similar to QS9000 series) and complimentary obligations associated with aerospace electronics manufacturing (MIL-PRF-38534). Experience in practical application and cultural development of structured problem-solving and continuous improvement tools, including 8D, lean manufacturing and lean sigma, goal deployment project management, and more.

References

Jonathan Losk, 818-***-****. Prior co-worker and VP of Clinical Engineering.

Michael Moody, 812-***-****. Prior co-worker and Supplier Development Engineer.

Kathy Berg, 480-***-****. Present co-worker and Regulatory Affairs Rep.

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