Valerie Bauer Email & Phone Number

Greater Minneapolis-St. Paul Area

Fridley, Minnesota

Principal Reliability Engineer, Repair and Analysis, Postmarket Quality (2009 to 2015). – Supported infusion system technicians and RPA (Returned Products Analysis) Lab in the analysis of returned devices for input to the tracking database. – Assisted with new and revised procedures and work instructions; responded to internal and external information requests on complaints, device returns, and lab analysis. – Worked with design, reliability, CAPA engineers; and complaint handling staff to complete returned product analysis and reporting. – Wrote RPA's Risk Analysis and Justification for Reduced Analysis on Infusion Systems in 2011. – Researched historical data and presented the Infusion Systems summary for the quarterly Neuro Product Performance Review from 2009-2014.Principal Quality Assurance Engineer, Released Systems Product Quality, (2007 to 2009). – Led field communication planning and implementation, deliverables development, and coordination with US and OUS cross functional teams. – Managed communications with US customers and the FDA.– Responsible for final versions of field action plans, and customer and regulatory documents, with final input and approvals from executive management. – Responded to questions from internal staff, customers and the FDA. – Authored updates to the Business Unit Field Action Procedure to meet requirements of corporate policies, internal audits, 21CFR7 (Enforcement Policy) and 21CFR806 (Corrections and Removals).Principal Reliability Engineer, Reliability and Software Quality Assurance Group, (2005 to 2007).– Provided Design Assurance input and support on new product development projects and Continuation Engineering projects. – Wrote team reliability deliverables for risk management, standards assessment and conformity assessment; provided input, review and approval on cross-functional deliverables. – Participated on internal audit teams coordinated by the Quality Systems group.

Cardiovascular Group, Maple Grove, Minnesota

– Provided compliance oversight on new product development project teams to assure that internal and external standards and regulatory requirements were met. – As a Core Team Member for DA, coordinated the work of DA team members, project-level risk management activities, design verification phase activities, and communications with extended team members, to assure that project deliverables met timelines. – Supervised testing, analyzed results, and documented findings for verification and validation testing. – Wrote, revised, and provided oversight for completion of test plans, protocols, and reports, equipment qualifications, hazard analyses, FMEAs, quality plans, failure investigations, design transfer plans, and gap analyses. – Participated on training teams for Process Validation activities and DHF Auditing.

Quality Assurance Department, Bloomington, Minnesota

– Provided customer support in the production and delivery of aerospace aluminum and magnesium castings. – Internal audit scheduling and coordination with functional groups. – Conducted Internal Audits to comply with AS 9000, ISO 9002, and Boeing D1-9000 requirements: planned, documented activities, and presented results to the management team.

Bloomington, Minnesota

- Employed in the Advanced Manufacturing Technology, Engine Products Group. - Developed manufacturing cost estimates for new and revised air and liquid filtration assemblies, make-versus-buy decisions and competitive comparisons. - Wrote the department’s Cost Estimating Procedure to comply with QS-9000 requirements. - Internal Quality Audit Program auditor for QS-9000 system.

Shakopee Components Plant, Shakopee, Minnesota

- Supported components produced in the Punch Press Area. - Supervised inspectors on three shifts. - Maintained inspection equipment calibration records, calibration work instructions and inspection procedures. - Worked with engineers and assembly staff to resolve component problems and to evaluate components made from new tooling. - Internal Quality Audit Program auditor for ISO 9002 system. Led biweekly quality review meetings.

Bloomington, Minnesota

Four positions with increasing responsibility.-- Manufacturing Engineer (Engineer III), Manufacturing Engineering Department, North American Division. Responsible for refrigeration coil and tubing subassembly processes in 5 plants. Coordinated acquisition of capital equipment for plant processes and production lines. Minneapolis Plant Internal Quality Audit Program participant, 1994-1996. -- Mechanical Engineer, Process Engineering Group, North American Division. Worked with cross-functional teams to improve systems to manufacture product, such as developing and producing assembly drawings and instructions and participating on the ISO 9001 Readiness Audit Team for the Montgomery, AL facility.-- Test Technology Engineer (Engineer II), Engineering Test Laboratory, Corporate Development Division. Test methods and systems development and documentation. “Team-building for Quality” Instruction Team Member, 1992-1993.-- Components Design Engineer (Engineer I), Technology Integration Department, International Division. Developed and performed component qualification and performance tests. Business Unit Total Quality Fitness Review Team Member, 1991. Supplier Quality Improvement Team Member, 1991-1992, wrote the team’s final report which became TK Quality Standard 00.13.14: Supplier Quality Improvement Program (an auditing and scoring system).

Bloomington And Plymouth, Minnesota

Engineering Applications Support, Energy Management DivisionAssisted in the development and delivery of Power Plant/Process Plant Design and Management software products. Wrote test plans, test reports, product documentation, and demonstration materials.

Education record

Sabhal Mòr Ostaig (Scottish Gaelic Certificate), University of St. Thomas (MBA), Texas A&M University (BA Mechanical Engineering), Lansing.

An Cùrsa Inntridigh, Certificate, Gàidhlig

Sleat, Isle of Skye, Scotland

Mba, Manufacturing Concentration

St. Paul, Minnesota

Bs, Mechanical Engineering

College Station, Texas

Ba Psychology

Rochester, Michigan

Associate Of Arts & Sciences (Aas), Architectural Technology

Lansing, Michigan

Ongoing, Technical

- Continuing education includes seminars and online courses in Engineering, Quality Systems/Compliance, and Scottish Gaelic. - 2022 –.