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Quality Assurance Manager

Painesville, OH, 44077
August 11, 2012

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440-***-**** • 558 Walker Lane • Painesville, OH 44077



Seasoned QA Management professional with over 25 years’ experience in quality assurance, production, and new product launch in the tool and medical device industries. Proven expertise in Capa closure, auditing, FDA / ISO auditing, and supplier development/control. In-depth knowledge of cGMP, FDA and ISO13485:2003, Lean Manufacturing (Kaizen), Gage R&R, CALIBRATION, SPC, FMEA, validation, audit, problem resolution, supplier development, and customer liaison. Recognized for stellar ability to manage manufacturing operations with rapid promotion throughout entire career. Six Sigma Certified. Proficient in Minitab Statistical Software, AS400, Gagepack EZ 7.5, Excel, Word, Power Point, and Publisher.



• Use of Six Sigma methodologies to structure

• QA department of 16 employees. Reduce lost workdays by 12% with implementation of machine guarding program.

• Improve work flow 20% through restructure of work schedules.

• Help implement ISO:13485.

Cost Saving:

• Reduce budget by $60K/year by combining workstations.

• Reduce yearly budget by $100K by restructuring final inspection process.

• Reduce scrap with improved operator training.

• Currently saved 80 man-hours per week by implementing lean practices in inspection.

Quality Assurance:

• Work closely with FDA auditors.

• Maintain certified quality systems.

• Led Younquist Medical team in ISO13485:2003 certification, minimization of CAPAs, improved CAPA closure time, improved Complaint closure time, and problem solving.

• New product validation and document control


Astro Medical, Mentor, OH

QA/RA MANAGER, Jun 2011-

Privately held Medical Device Contract Manufacturer producing full line of Spinal implants. Manages Quality, Regulatory, validations, and manufacturing.

• Reduced CAPA and Complaint Closure to 30 days from 45 day average.

• Led FMEA and Risk Analysis.

• Lead internal Auditor/Lead Vendor Auditor .

• Oversee new product development.

Spinal USA, Pearl, MS

QA/RA MANAGER, Jun 2009 – Jan 2011

Privately held Medical Device Manufacturer producing full line of Spinal implants. Manages Quality, Regulatory, validations, and manufacturing.

• Reduced CAPA and Complaint Closure to 30 days from 45 day average.

• Led FMEA and Risk Analysis for 510K submissions.

• Lead internal Auditor/Lead Vendor Auditor .

• Oversee new product development and launch through 510K submissions.

• Led manufacturing team in establishing in house manufacturing.

• Promoted to Director of Operations/COO in January 2010.

Endotec, Orlando, FL

QA/RA MANAGER, Apr 2008 – May 2009

Privately held Medical Device Manufacturer producing full line of implants. Managed manufacturing and QA functions, including validations in a facility of 45 employees.

• Management representative for FDA and ISO interface and audits.

• Responsible for setting up Sterilization and packaging in house. Company sold to Korean Bone Bank.

• Responsible for all QE functions (IPs, IQ,OQ,PQ, etc.)

• Promoted to Director of Operations December 2008.


440-***-**** • Page 2 of 2

Youngquist Medical, Fort Myers, FL

QUALITY ASSURANCE Manager, Nov 2006 – Mar 2008

Managed quality for two-plant structure for Medical Device start-up company specializing in spinal plates, bone screws, caudal bearings, and spinal instrumentation. Report to President in a facility of 50 employees.

• Set up Quality System, class 10,000 clean room, purchasing, quoting, and production flow.

• Responsible for multi plant Quality Systems including Regulatory Affairs, Quality Engineering, MRB, and institution of NMR. Plant wide responsibility for training and training records.

• Led ISO:13485 Implementation team.

N.G. Instruments, Warsaw, IN


Managed operations of cutting tool manufacturer for the Medical Devices in a facility of 75employees. Responsible for all daily QA and QE functions, restructuring of QA department, Regulatory Department,SCARs, CAPAs, MRB and training.

• Written procedures and programming of Metrology equipment.

• Restructured Quality Department by means of Six Sigma and Lean manufacturing. Instituted automated inspection.

• Lead Auditor

DePuy Orthopedics, Warsaw, IN

QA SUPERVISOR, 1983 – 2004

Promoted from CNC Team Leader in 1998. Reported to the Plant QA Manager of a $1 Billion division of Johnson & Johnson manufacturing varied line of Class III orthopedic products, with 16 direct reports and 1200 employees.

• Managed all third shift operations, including work schedules and maintaining third-shift tool room.

• Provided technical expertise to QA and production personnel.

• Performed audits, corrective actions, inspections, and maintained FDA files.

• Leader of Six Sigma project which reduced inspection time, increased productivity, and saved 100K per year with no financial investment incurred on project.

• Lead internal auditor.

• Perform root cause and failure analyses on any returned product.

• Managed clean room and sterilization quality, i.e.; bio burden count, particle count, and verification of gamma sterility.


Bachelor of Science in Business Administration, 2002


IPFW, Fort Wayne, IN


Six Sigma Green Belt Johnson & Johnson 2002

Auditor Certification Johnson & Johnson 2001

80 hrs Business Management Training Johnson & Johnson 2000-2004


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