Mike Mcnally - Retired Email & Phone Number

Greater Seattle Area

Applying quality engineering principles to address product and process issues, ensure reliable new and/or changed product development, lead investigations, and provide general support of the quality system. Working on a wide range of quality problems related to Quality Systems, Product Quality, and Supplier Management. Most recently working on the.

Woodinville, WA

Orchestrated all quality activities related to the company's $450M line of cardio-related fitness products, collaborating cross-functionally with design and manufacturing teams in Woodinville and Taiwan. Successfully managed budget of $300K. Maintained Quality Engineer role and responsibilities while leading the team of engineers and inspectors. .

Woodinville, WA

Managed the quality systems included warranty reporting, pFMEA process, MRB reviews, disposition of FPA packages, and QA drawing signoffs in Agile. Conducted extensive research into identifying failure points and product issues which reduced annual warranty expenses from $7M to less than $4M through improved quality standards, testing, and engineering. .

Seattle, WA

Led development of the manufacturing quality system for the first Seattle-based company to receive successful implantable device approval by FDA. Responsible for all manufacturing quality functions including sterilization approvals, inspection and calibration. Obtained 510K and ISO 9000 certificates. Completed a one-year shelf life packaging Design.

Bothell, WA

Oversaw product quality and compliance with all applicable agency, safety, and cGMP requirements for a broad range of medical devices. Coordinated TUV and CSA product safety reviews for a Class III implantable heart assist device. Served as product quality representative for FDA audits.

Redmond, WA

Responsible for managing product quality and compliance cardiac monitors and defibrillators.inspection tests. Optimized of the Field Performance Reporting System.

Redmond, WA

Led team of up to 25 quality control technicians and inspectors, ensuring quality in all company products, including prototype and final testing, scheduling equipment repair, equipment purchasing and budgeting.