John C. Lemieux

*** ****** ******

Seekonk, Massachusetts 02771-5108

Phone: 774-***-**** E-Mail: ad1ek0@r.postjobfree.com

Professional Summary:

Team member with Engineering to develop new medical devices and improve existing products to meet FDA requirements.

Team member to work with global suppliers to meet ISO 13485 (FDA) requirements for packaging, identification and traceability of medical products.

Project Leader of team that achieved 510k approval (FDA) for new medical device. Project included construction of clean room and manufacturing production line to produce the medical device.

Ten years’ experience working with GMP in a manufacturing environment of medical devices to achieve FDA 21 CFR Part 11 compliance.

Familiar with DOD standards and specifications. Working with DOD suppliers and providers of products.

Manager and team leader with hands-on experience with CAPA investigations to complete Root Cause Analysis to resolve problems and develop resolutions. 10 years’ experience leading continuous improvement programs using problem solving techniques to improve the process, QMS and /or product quality. Techniques used Brainstorming, Fishbone diagram, Pareto Analysis, D/PFMEA, Histograms and other Statistical Methods.

Experienced using Lean Manufacturing techniques to improve the manufacturing process and product line flow.

Achieved certification and maintained certification for TS 16949, ISO 9001, ISO 13485, AS9001 Quality Management Systems

Completed PPAPs for automotive industry to meet TS 16949 Quality Standard requirements for the approval of products to support the automotive industry.

Project leader that achieved Quality Systems approvals for FAA and Boeing Corporation AS-9100 highest aerospace commercial rating. Achieved repair station status from the FAA.

Supplier Quality Manager managed a supply chain of over 300 suppliers including domestic and foreign suppliers from Spain, China, Japan & Mexico.

Instituted SPC system for milling, turning, plating, screw machines, CNC machines and plastic molding to reduce scrap and monitor production processes.

Initiated and developed automatic test system for rotary switches for the nuclear to reduce electrical failures and improve the process.

Reduced scrap rate from 15% of production volume to 3% of production volume by the introduction of a SPC program and implementation of a Continuous Improvement Program.

Member of engineering team that designed and developed several new products including EII and PAI high-speed connectors. Increasing company market share and position.

Work Experiences:

Proven Process/Nextphase Medical Devices

Quality Engineer (Contract duration 2 years completed)

Responsible for product support including IQ, OQ and PQ validation of equipment and processes to meet FDA requirements per ISO 13485. Duties included meetings with customers and internal review of documentation, systems and equipment requirements needed to produce product to meet FDA/customer requirements. Work with internal and external engineering teams to transition to production Additional responsibilities monitoring CAPA’s, lead audit for supplier audits to FDA requirements for medical devices, supplier rating system and supplier ASL listing/database.

Covidien (Medtronic), Inc. Mansfield, Massachusetts

Quality Engineer (Contract duration 5 years completed)

Responsible for the IQ, OQ and PQ validation of equipment and packaging barcode design change to meet UDI/ FDA requirements per ISO 13485. Duties included meetings with suppliers Worldwide to review documentation, systems and equipment requirements needed to produce barcodes to meet GS1 requirements. Work with internal and external team’s to investigate and resolve CAPA in a timely manner as needed.

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Spectra Systems, Inc., East Providence, Rhode Island

Quality Engineer (Contract to Permanent)

Responsible for product quality from design to manufacture for a laser verification system manufacturer.

Duties included customer interaction, design review, production meetings, and supplier control. Additional duties included

inspection of all incoming materials, inspection documentation, implementation, and enforcement of

established procedures.

NESTEC, Inc., New Bedford, Massachusetts

Quality, Safety, & Environmental Manager

Responsible for the quality, safety, and environmental issues for a reclaim wafer manufacturer. Duties included the documentation including PPAPs, implementation and enforcement of established procedures. Additional responsibilities are the required reporting and documenting environmental emissions to the DEP and EPA State, Federal and local authorities.

Electroswitch Inc., Weymouth, Massachusetts

Quality Manager

Responsible for documenting, maintaining, planning, and implementing a quality system to meet the

requirements of ISO 9001, NUPIC, Military, and Utility regulatory requirements for an electrical rotary switch manufacturer. Additional duties included customer documentation including PPAPs when required, certifications and material traceability. Developed and maintained automatic electrical test inspection equipment and led a laboratory staff to meet production needs of the corporation.

Education:

Hyde Park High School, Diploma

Johnson & Wales College, BS Degree Business Management

ASQC, Management and Advanced Statistical Certification

Crosby's Quality Improvement, Certificate

Problem Solving Techniques, Certificate

P-E Batalas, ISO-9000 Lead Auditor Certification

NQA, ISO 9000:2000 Lead Auditor Training Certification

QSG, ISO 9001:2008 Process Auditor Training

Military:

United States Air Force - Highest Rank Sergeant - Honorable Discharge

Computer Skills:

Microsoft Windows, Word, Excel, Power Point, and Project,

SPC & Quality Software - JMP, FAN, SQC, Gage Trak, Statit, ABC Flowchart, All Clear, Minitab,

References:

References are furnished upon request.

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