Quality Assurance Manager

**** ****** ***** • GREENSBORO, NC *****

CELL 201-***-**** • E-MAIL abnpo4@r.postjobfree.com

DAVID MEILY

QUALITY • O PERATIONS • C ONTINUOUS IMPROVEMENT

ENVIRONMENTAL • S AFETY • C OMPLIANCE

Extensively experienced and accomplished visionary professional with 20+ years of skill and knowledge

development in all attributes of results oriented leadership. Proficient in effective cross-functional

management of quality, operations, systems, environmental, safety and engineering. Skilled and decisive

multi-unit manager focusing on people, self, thought and results leadership to develop strong functional teams

with ability to manage for results, build collaborative partnerships and influence others across organization

lines. Proven track record and success in increasing corporation profitability through effective decreasing

operating expense through cost management, development/delivery of internal and external customer

productivity initiatives beyond established targets and implementation of operational processes and systems.

Ability to thrive in dynamic and fluid environments while remaining focused, resilient and practical. Extensive

global experience in Japan, China, United Kingdom, France and Philippines. Participated in start-ups or joint

ventures in China, Mexico and Dominican Republic.

Core Competencies

• • Quality Systems & Quality Control • Continuous Improvement Programs

P&L Management

• • Six Sigma Black Belt (Six Sigma Academy) • Lean Manufacturing

Supply Chain & PPAP

• • Validation & APQP • Large & Multiple Unit Operations

CAPA

• • Environmental Permitting & ISO 14001 • Governmental Regulation Compliance

Project Management

• • International Operations • ASQ Certifications: CQE, CQM, CQA

Sterile Mfg. & Packaging

• FMEA and Control Plans• Health & Safety Planning & Development • Union & Non-union

• • FDA Medical Device Regulations, QSR & cGMPs • Greenfield Mfg. Start-up Experience

ISO 9001& ISO 13485

EDUCATION

BS CHEMISTRY, MILLERSVILLE UNIVERSITY OF PENNSYLVANIA

PROFESSIONAL EXPERIENCE

STRYKER ORTHOPAEDIC, Mahwah NJ 2008-2009

$2.5 Billion division of Stryker Corporation – 2,400 employees, manufacturer of artificial joints, spinal rods and

screws, vertebral discs, bone cement, and other orthopedic device; includes the manufacture of a large range of

instruments.

Manager of Operations Quality Engineering

Reporting to Director of Operations Quality. Responsible for Quality Assurance, Validation (process & software),

Final Inspection, FDA Compliance, and Continuous Improvement. Six Direct reports and 88 indirect reports.

GUILFORD (performance fabrics), Wilmington NC 2005-2008

$500 million subsidiary of Cerberus Holdings - 2,600 employees. Supplier of knit & woven Headliner and Bodycloth

(seating fabric) to Toyota, Honda, GM, Chrysler, Ford, Hyundai, BMW, Mercedes and other OEMs.

Director of Quality and Continuous Improvement

Reporting to COO. Responsible for Quality Assurance, Quality Control, and Six Sigma, dotted line responsibility for

the Lean Manufacturing Group. Nine direct reports, 29 indirect reports. Responsible for Quality and Continuous

Improvement Groups at eight manufacturing sites in the US and Europe. Set up reporting and control systems for

eight international sites, intranet and web-based systems. Developed Global Environmental Program including

compliance and “Green Policy”.

DAVID MEILY (page 2)

GST AUTOLEATHER, INC., Hagerstown MD 2004-2005

$300 million subsidiary of Citigroup Strategic Industries LLC (SILLC) - 1,100 employees. Supplier of seating leather

to Toyota, Honda, Ford, and Chrysler

Director of Quality

Reporting to the Executive Vice-President. Responsible for Quality Assurance, Quality Control, Supplier

Quality, Reliability Engineering, Continuous Improvement and site registrations. Responsible for seven

manufacturing sites in US, Mexico, China and Dominican Republic.

HIGHLAND INDUSTRIES INC., Kernersville NC (subsidiary of Takata Restraints) 1999-2004

Eight billion dollar corporation – 3 international sites - 700 employees; production of fabric and products for

automotive safety devices, medical, aviation and industrial uses, supplier to GE Medical, Hill-Rom, Honda,

Toyota, Nissan, Chrysler, and NASA. Products include blood pressure cuffs, IV bags, inflatable coverings for

hospital bedding, Space Shuttle fuel materials, aviation life vests, and airbags.

Director of Quality

Reporting to the Executive Vice-President. Responsible for Quality Assurance, Supplier Quality, Validation,

Internal Audit, Reliability Engineering, Six Sigma and Lean programs. Responsible for all Quality Systems

including compliance to FDA cGMP – 21 CFR 820, TS 16949, A2LA and ISO 14000 programs. Responsible for

validation protocol and execution, FDA-compliant documentation, laboratory testing, material disposition,

customer complaints, incoming material certification & testing, quality and operations reporting.

BTR SEALING SYSTEMS, Reidsville NC (British Tire & Rubber) 1997-1999

Sixteen billion dollar corporation – 600 employee site; production of extruded rubber sealing systems for

automotive, Tier 1 supplier to Ford, Chrysler and BMW.

Regulatory Compliance Manager

Reporting to the Plant Manager. Responsible for QS 9000 Environmental and Safety Programs. Responsible for

laboratory testing, permitting, and reporting to compliance agencies. Directed preparation efforts for QS 9000

registration, attained in 14 months Developed pollution control strategy for compliance, attained bids, selected

vendor and directed installation & engineering changes to accomplish 95% VOC capture and destruction.

Received BTR Automotive Division, North American President’s Award (1998). Negotiated fines and settlement

with NC DEHNR for prior existing site environmental citations.

KONICA MANUFACTURING USA, Greensboro NC 1988-1997

Four billion dollar corporation – 350 employee site; production of photographic paper

Director of Quality, Environmental & Base Paper 1993 -1997

Reporting to President, responsible for four staff departments including Quality Assurance, Environmental

Compliance, Base Paper Materials and ISO 9002 Compliance. Designed and implemented Statistical Process

Control at two US sites. Directed improvement efforts to win the “Konica Highest Quality Award” in 1995 for

Quality and Supplier Quality programs. Responsible for purchase agreements, purchase/release and design of

base paper, $100 million dollars annual purchase. First site registered to ISO 14001 (Environmental Standard) in

North Carolina.

Director of Manufacturing 1988–1993

Reporting to President, P&L responsible for Manufacturing Operations in a greenfield start-up.

BERKLEY PRODUCTS INC, Akron PA 1980-1988

Manufacturer of technical coatings – Laboratory Manager, Plant Manager, General Manager

OTHER EDUCATION

American Society for Quality CQA, CQE, CQM, Certified ISO Lead auditor

Continuing Education: Lean Manufacturing, Kaizen, Layered Process Audits (LPA), Self Directed Work Teams,

Leadership Development Program (LDP) at the Center for Creative Leadership, FDA Medical Device QSR Regulations

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