Senior Supplier Quality

• May 2021 - Present

Senior Supplier Quality Engineer

• Jun 2010 - May 2021

Provide technical leadership for all aspects of quality engineering throughout the product realization process while handling multiple projects from product inception and development through manufacture and customer use to ensure product meets defined quality standards regulatory requirements.

Senior Supplier Quality Engineer

• Jun 2010 - May 2021

Senior Supplier Quality Engineer

• Jun 1999 - Sep 2009

Conduct audits to ensure suppliers meet all FDA and ISO standards. Steer mechanical and electrical engineers in medical part design, material selections, and technology options for both plastics and metals. Initiate, track, and close CAPAs. Guarantee manufacturability through process capability and Gage R&R studies of products, compiling detailed quotes, lead times, and tooling specifications. Drive activities of Incoming Quality Assurance department, including building and leading top-performing 14-member Inspection team. Lead teams to resolve complex medical device manufacturing issues for suppliers onsite, which fortify relationships and lead to increased business growth and profitability. Show less

Incoming Quality Assurance Section Manager

• Nov 2005 - Sep 2007

Managed an incoming quality inspection group of 14 technicians inspecting up to 3,250 lots, 150 first articles, and 30 engineering evaluations of mechanical and electrical components and assemblies per month. Initiated departmental cost savings and efficiencies, reviewed prints for new projects, conducted gage R&R studies, worked with suppliers and engineers to align inspection processes and techniques. Managed an incoming quality inspection group of 14 technicians inspecting up to 3,250 lots, 150 first articles, and 30 engineering evaluations of mechanical and electrical components and assemblies per month. Initiated departmental cost savings and efficiencies, reviewed prints for new projects, conducted gage R&R studies, worked with suppliers and engineers to align inspection processes and techniques.

President/Owner

• Feb 1991 - Dec 1998

Owned and operated a company that designed, built, repaired, and processed, one and two color, laminated, and insert injection molds. Reviewed existing molds and made design and processing changes to improve part quality and yield. Reviewed mold designs for other companies both foreign and domestic and made design changes to improve mold performance and reduce costs. Owned and operated a company that designed, built, repaired, and processed, one and two color, laminated, and insert injection molds. Reviewed existing molds and made design and processing changes to improve part quality and yield. Reviewed mold designs for other companies both foreign and domestic and made design changes to improve mold performance and reduce costs.

Class A Moldmaker

• 1990 - 1991

led a team of moldmakers in the construction of plastic injection molds led a team of moldmakers in the construction of plastic injection molds

Moldmaker

• 1986 - 1989