Quality Engineer Manager

Profile

Results-oriented Quality Engineer known as a consistent team player with skilled technical abilities; extensive electronic/electrical and mechanical experience within both manufacturing and testing laboratory environments. Fully knowledgeable of International, Domestic and Regulatory Standards and Directives including Medical Device Directive and EN60601) relating to product safety and ISO13485:2003 as well as CFR 820, and AS9100C Aviation Space and Defense. Conscientious, highly motivated individual capable of working independently and as a member of an integrated team.

Professional Experience

Quality Manager (Contractor)

June 2017 – Present

Anuva Manufacturing Services

Contract Manufacturer (EMS)

Responsible for redeveloping and obtaining the current 2016 registration versions of ISO 13485:2003 and AS9100C for the Melbourne manufacturing facility.

Liaising with customers in the Medical Device and Aerospace industries concerning quality, regulatory and standards issues.

Maintaining Manufacturing History Records for customers.

Liaising with standards and registrar companies such as BSI, UL, CSA, and ETL.

Regulatory Affairs including FDA Part 820, and ITAR.

Quality Engineer (Contractor)

April 2016 – October 2016

DRS Technologies Inc., Melbourne Florida

Aerospace and Defense Industry

Develop/update AS9100C Quality Management Systems- Requirements for Aviation,

Space and Defense Organizations

Perform Internal Audits, train internal auditors

Assist Quality Management in establishing attainable goals and objectives;

oidentifying realistic Key Performance Indicators and reporting progress during bi-weekly Management meetings

Assist during DCMA Audits

Assist during AS9100 surveillance Audit

Function as Program Quality Engineer

Director of Quality and Regulatory Affairs (Contractor)

November 2013 – April 2015

Perry Baromedical Corporation, Riviera Beach Florida 33404

Hyperbaric Chambers Development/Manufacturer

Direct QA/RA for a hyperbaric Chamber manufacturing operation. ISO/CE/CMDCAS/FDA

Responsible for maintaining the current registered ISO 13485:2003 Quality System, FDA registration, ASME and PVHO registration, Maintaining Device History Files

Interfaces with all external safety and regulatory organizations; FDA, CSA, ASME

Projects including revitalizing ISO 13485 QMS, assisting in problem solving for day to day occurrences

Quality Assurance & Regulatory Affairs Manager

October 2012 – November 2013

Airon Corporation, Melbourne Florida 32934

Medical Device Developer/Manufacturer

Manager QA/RA for a pneumatic ventilator manufacturing operation. ISO/CE/CMDCAS/FDA

Functioned as Development Engineer writing Engineering Change Orders.

Established in process testing to improve throughput at final calibration and test.

Interfaced with 3rd party (ISO/CE) and regulatory (FDA) auditors.

Responsible for obtaining regulatory registrations with Singapore and Thailand.

Senior Quality Engineer (Contractor)

May 2011 – April 2012

GeNO, LLC Cocoa Florida 32926

Medical Device/Pharma Manufacturer

Responsible for working closely with R&D in the development of Design History Files for the FDA submission of two combination products to the FDA. One device was submitted on a 510(k) the other was submitted as a New Drug Application (505b2).

Advised R&D on Regulatory, Safety and EMI/EMC requirements. Qualified major contract manufacturer as a supplier of the finished devices. Wrote component specifications for all critical and off the shelf components. Responsible for the Design History File; Design input, Design output, Design Reviews, Design verification and validation (software and electro-mechanical), DFMEA, Design transfer and Design changes.

Senior Quality Systems Engineer

September 2007 – April 2011

MC Assembly Inc., Palm Bay Florida

Electronics Contract Manufacturer

Responsible for developing and obtaining ISO 13485:2003 and AS9100C registrations for the Palm Bay facility and the Fresnillo, Mexico facility.

Liaising with various medical device manufacturers concerning regulatory and standards issues.

Maintaining Device History Records for customers.

Liaising with standards companies such as UL, CSA, and ETL.

Regulatory Affairs including FDA Part 820, FAA Part 21 (Repair Station) and ITAR.

Quality Engineering Lead

October 2006 – September 2007

LungRx, Inc. Melbourne Florida

LungRx, Is a wholly owned subsidiary of United Therapeutics Corporation, Silver Spring MD.

Responsible for the development and registration of the company’s quality system to ISO 13485:2003.

Assisted in the development of an oral nebulizer for the administration of the drug Treprostinil to aid patients suffering from pulmonary arterial hypertension (PAH).

Worked closely with a contract design/manufacturing company in the submission and approval to IEC 60601 through Underwriters Laboratories Inc.

Developed user’s manual for the Nebulizer.

Assisted in the New Drug Application (NDA) submission for a combination product (drug and nebulizer) to the FDA.

Developed drug labeling protocol for packaging.

Quality Manager

February 2006 – October 2006

Perry Baromedical Corp, Riviera Beach Florida

Perry Baromedical is a manufacturer/developer of hyperbaric chambers.

Responsible for maintaining the current registered ISO 13485:2003 Quality System.

Interfaces with all external safety and regulatory organizations; FDA, CSA, ASME.

Projects included creating FDA 510(k) submission for updated hyperbaric chamber and rewriting ASME Quality Manual for Pressure Vessels for Human Occupancy.

Quality Engineer – Medical Devices

November 2005 – January 2006

MC Assembly and Test, Incorporated, Palm Bay Florida

MC Assembly is a national leader in the contract manufacturing industry.

Providing turnkey solutions to the original equipment manufacturer that can reduce cost, increase quality, and maintain product availability.

Responsible for maintaining and improving the Registered ISO 9001:2000 Quality System.

Functioning as company consultant in all matters concerning the Food and Drug Administration; Registration, Listing, and Validation and Verification of processes, Underwriters Laboratories and various other national and international safety organizations.

Instrumental in training the production and supervision staff on RoHS (Restriction of Hazardous Substances).

Performed daily Quality Engineering functions such as; Corrective and Preventive Action, Returned Merchandise, Deviations, New Product Introduction, Receiving, and In process and Final Inspection.

Manager Quality Assurance and Regulatory Affairs (Start-up)

April 2003 – November 2005

NUVO/Cybersonics, Incorporated, Erie, Pennsylvania

Manufacturer and developer of Surgical lighting, Video Monitor systems, Lithotripsy equipment and Cardiac Canalization equipment, Manufacturers Representative ISO13485, FDA Correspondent, UL/CSA, MDD, EMC advisor.

Responsible for implementing the (ISO13485, QSR, CFR 820) Quality System.

Maintaining FDA Registration and Listings, including writing and submitting the FDA 510(k) for the lithotripsy system.

Additionally responsible for Product Safety Engineering.

Working closely with Development Engineering (IEC 60601) and submitting products for Listing/Certification to Underwriters Laboratories Inc. and the Canadian Standards Association.

Quality Systems Engineer

June 1998 - April 2003

ACU-RITE Incorporated, Jamestown, New York

Manufacturer of optical encoders and digital readout systems for the machine tool industry.

Responsible for the company’s ISO9001 Quality System.

Team Leader directing the revitalization of the Supplier Quality Assurance Team.

Main contact and liaison for ISO Registrar.

Completed the update of the Quality Manual to conform to ISO9001:2000.

Regulatory /Standards Quality Engineer

May 1987 - March 1998

LEICA, INC., Optical Products Division, Buffalo, New York

International manufacturer of microscopes, refractometers, and diagnostic medical instruments.

Responsible for the company’s standards/regulatory and product safety affairs.

Official Correspondent to the Food and Drug Administration.

Successfully prepared, submitted and maintained 510(k) applications for In vitro Diagnostic Devices class 1

and 2; including Hemicytometers, Bilirubinometers, T/S Meters, Refractometers, Non-Contact Tonometers, Colony Counters, Compound and Stereo Microscopes and Accessories.

Maintained all Device listings, and Establishment Listings for various sites, maintained Quality System Manual; developed and maintained electronic customer complaint system.

Responsible for product/package marking, primary member of a Beta site for Clinical Test and lead member of the Product Recall Team, contact person for Department of Defense Quality Assurance Representative.

Responsible for interpreting D.O.D and F.D.A. contracts.

Secured Underwriters Laboratories (UL) listings for the Optical Products Division’s products from conception through product life cycle. Worked closely with Research and Development, and Manufacturing Engineering to ensure compliance with product safety standards, PPAP, FMEA requirements. Functioned as one of the architects in developing Leica’s ISO 9001 Quality Manual, writing procedures and selecting the Registrar. Additionally responsible for the Material Review Board and Calibration.

Responsible for receiving inspection, in process inspection and final inspection, calibration, supplier qualification and supplier surveillance.

Assumed responsibility for redeveloping and upgrading existing electrical and electronic products to comply with European standards.

Realized cost savings in excess of $250,000 in materials and manpower, resulting in the simplification of assembly processes.

The company is now eligible to certify all electronic/electrical products with the CE mark, and many products bear the highly regarded VDE mark.

Managed a section of the Quality Organization known as Returned Merchandise.

Responsible for four individuals that handled the day-to-day operations of that department to include; Shipping, Receiving, Inspection and Clerical.

Responsible for Customer Complaints.

Responsibilities included interfacing with and satisfying customers that included Medical Doctors, Nurses, Scientists and the full range of the public.

Responsible for making sure warranty repairs were returned or replaced to the customer within five days.

Responsible for the processing of all credit returns.

Education and Training

Certificate, ISO 13485:2003 Internal Auditor, TUV

Certificate, FDA QSIT Program

Certificate, CE Marking, BSI

Certificate, Microsoft Access 2.0, levels 1, 2, 3, and Developer, Ikon Business Solutions

Certificate, Laboratory Equipment UL 3101 and CE Marking Strategies for European Compliance Underwriters Laboratories, Inc.

Certificate, ISO 9000 Auditor Training, State University of New York at Buffalo

Certificate, Managing Total Quality, 3M Company (8D technique)

Certificate, Excellence Training for Supervisors, Xerox Corporation

FDA Good Manufacturing Practice Courses, Food and Drug Administration

Electrical Technology and Technical Writing Courses, Erie Community College

Signal School, Electronics, GCA Repair, United States Army

Chemical, Biological and Radiological Warfare, United States Army

Diploma, Bishop Neumann High School

Proficient in the use of Windows, Word, Microsoft Access, and Excel

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