Medical Device Quality Control

Peter C. Page

*** *** *** ******, ******** Springs Colorado 80921

Phone: 919-***-****

E-Mail: *******************@*****.***

Dedicated and versatile manufacturing Supervisor/ Operator with over 18

years progressive experience in all aspects of high end, and high speed

production, design, and release of FDA regulated and ISO 9001 certified

Surgical Instruments, Devices, and Drugs.

Professional Experience

GlaxoSmithKline, Zebulon, North Carolina

MDPI Facility- (Multiple Dose Powder Inhalants)

November 2009 - March 2010 (Contract Position, Contract ended)

Drug Production Operator/ Packaging Quality Control

. Operated, monitored, and maintained high speed drug manufacturing

and drug packaging equipment and machines.

. Ensured drug safety and effectiveness through strict adherence to

SOP, and cGMP compliance and in-process checks (IPCs.)

. Effectively practiced Drug Safety process improvement, and drug

safety monitoring at 6 manufacturing/ Packaging stations

(Machines.)

. Observed and trained in all Aseptic gowning procedures and

techniques.

. Observed and trained in all Clean room Aseptic cleaning, and Waste

Management techniques and procedures by internal SOPs and FDA

requirements.

. Used and certified in PAPR (Powdered Air Purifying Respirators.)

. Maintained and ensured accuracy on all Drug Batch Documents, Forms,

and Training records.

. Trained in Chemical and Bio-Hazard safety and control, and all PPE

(Personal Protective Equipment) involved in the use and handling of

such components used in drug/ Medical Device manufacture.

Teleflex Medical, Research Triangle Park, North Carolina

March 1997 - February 2009

Production Supervisor/ Craftsman

. Maintained production line operations by analyzing,

troubleshooting, and solving production process problems observing

cGMP guidelines, and making any necessary machine setups,

adjustments or repairs.

. Proficient in all aspects of medical device/ stainless steel

fabrication. Including High speed/ low speed polishing and

grinding, using abrasive belts and wheels.

. Use of all measurement and testing equipment, including calibrated

gages, micrometers, Vernier calipers, overlays, comparators, Stereo

microscopes, tooling and fixtures.

. Responsible for final inspections and all collaborative production

documentation and line clearance within company cGMP, FDA, and ISO

guidelines.

. Maintain all tools and equipment in tool crib.

. Interpret blueprints, drawings, and inception documentation for

existing or new device designs.

. Can effectively hand craft all types of stainless steel

applications and prototypes.

. Responsible for writing and enforcing the use of standard operating

procedures (SOPs).

. Maintained a safe and efficient production environment with no lost

time accidents in over Eight years.

. Exceeded internal and external customer requirements in quality and

production while maintaining a scrap rate of less than 1%.

. Played key lead in Teleflex Medical receiving ISO 9001

certification through SOP and cGMP process improvement and

restructure, and FMEA validation.

. Served as HACCP Coordinator for SGS audits.

. Process CAPAs, deviations, and non-conformances (NCMRs)

. Instrumental in developing new surgical instrument designs in

answer to competitors' product release.

. Created new process SOPs for manufacturing custom or accommodation

instruments.

. Responsible for all payroll editing and approval for all production

personnel.

. Extensive experience in technical complaint analysis and

resolution, working in conjunction with the Medical Affairs and

Quality Groups (QA & QC).

. Demonstrated presentation and negotiation skills at all levels of

the organization.

. Responsible for Operational Qualification and Performance

Qualification (OQ, PQ) in new

Device validations and life cycle testing.

. Managed departmental calibration events.

. Served on Safety Committee.

Horizon Surgical, Evergreen, Colorado

April 1992 - March 1997

Production Lead

. Lead a staff of 11 in Medical device production.

. Production contact during FDA Audit.

. Key in development and design of New Surgical Instrument releases

. Quality Control and Safety Lead

. Liaison for Sales Representatives and Surgeons.

. Processed100% of technical complaints to resolutions.

. Responsible for payroll editing and approval.

. Worked in clean room and on the production floor.

o In 1997 Horizon Surgical was purchased by Teleflex Medical.

I transferred with the company to North Carolina.

Computer Skills

. Microsoft Office Applications

. S.A.P. ERP System

. Q.A.D. ERP System

. Shop-Trac Pro Labor and Payroll Control System

. Pilgrim- Q-Mis Training and S.O.P Compliance system

. Web based applications

Training and Education

. Aseptic Gowning

. Drug Safety and Efficacy Training

. PAPR Certified (Powdered Air Purifying Respirators)

. ISO Procedures

. Current Good Manufacturing Practices (cGMPs)

. FDA Compliance

. Manufacturing Quality Systems Regulations (MQSR)

. 5S Shop Floor compliance

. Good Documentation Practices (GDP)

. Device Master Records (DMR)

. Failure Mode Effect Analysis (FMEA)

Contact this candidate