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 reduction and backlog of NCRs. Interim QC supervisor of the inspection department.

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.  Performed root cause and corrective action analysis, collaborating with design engineering, global sourcing teams, and external suppliers, which identified and permanently resolved product quality issues. Developed improved documentation related to all quality processes and warranty issues, reducing defect rates, improving response times, and allowing for faster training and onboarding of new engineers. Managed the quality audit schedule, performing routine end-of-the-line finished unit inspections which identified product issues prior to shipment. Designed an improved system to effectively monitor the field reliability utilizing company’s new SAP Business Objects.

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.  Led cross-functional product issue meetings - prioritized and documented issues, developed resolution plans utilizing 8D and DMAIC, assigned resolution ownership, established milestones and deadlines and tracked resolution progress; improved product through-put and customer satisfaction. QA Lead for NPI activities including new supplier approvals, life testing, software validation and agency/regulatory compliance. Leader of the dFMEA and pFMEA process, maintaining FMEA files, tracking progress and driving for item resolution and closure. This resulted in successful launches of six new products.

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 Verification Test, and completed the “EU Essential Requirements Checklist” required to meet compliance with ISO 13485 and MDD standards. Became the Subject Matter Expert on all applicable industry standards for sterilization. Served as lead quality contact during the initial FDA audit and successfully addressing an open CAPA issue. Demonstrated extreme resiliency and problem-solving skills under intense time constraints, when a flood contaminated the manufacturing clean room two months prior to the FDA audit. Supervised a complete teardown and rebuilding of the entire operation, leading to a successful audit. Developed and documented the manufacturing quality system from receiving and inspection through final product approval and signoff.

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.