MANUEL PERRY JR.

PO Box ***

Portsmouth, RI *****

Cell 401-***-****

SUMMARY

Over Thirty years experience in Quality Assurance Engineering/Management for Raytheon Portsmouth RI, DePuy Spine a Johnson & Johnson Company Raynham Mass, Symmetry Medical (Tecomet). Demonstrated interpersonal skills with fellow employees.

Working knowledge in the following areas.

Certified ISO 9001: 2001 Internal Quality Systems Auditor

Certified ISO 13485 Internal Auditor

ISO Auditor Internal / Suppliers

GMP/QS Requirements and Industry Practice

Ship to Stock Activities

Printed Circuit Boards

Military Standards

IPC Standard 610B

J-STD-001B, 002, 003, 004, 005, 006

ANSI/ASQC Z1, 4-1993 Sampling Procedures

Hardware Enclosures

Wiring Harness

Incoming Inspection Procedures

Certificate of Compliance Procedures

Artwork Inspection Verification

Vendor Rating System and Supplier Selections/ Approvals

Instructor

Vendor Validation Audits

Quality Representative at all Design Reviews

Annual / Semi Annual onsite Vendor Assessments

Quality Assurance representative for all MRB actions

Handling an FDA Inspection

Understanding the Japanese Medical Device Market

Lead Auditor with Specific Reference to ISO 13485

WORK EXPERIENCE

Symmetry Medical (Tecomet) New Bedford, MA 2013 – 2016

Supplier Quality Assurance Engineer (contract)

Responsible for Approved Supplier List

Contact for all incoming quality issues

Issue supplier non-conformance reports as required

Issue corrective actions requested when required

Contact suppliers with first time issues as a heads up and monitor for any future occurrences

Perform all supplier on-site audits per ISO 13485

Perform all supplier reviews to track delivery and Quality requirements

Approve new suppliers if requested

Create and approve all incoming inspection reports

Train Symmetry Medical new auditors to ISO 13485 & ISO 9001

Approver for all Quality Documents

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MANUEL PERRY JR.

PO Box 582

Portsmouth, RI 02871

Cell 401-***-****

DePuy Spine Raynham, MA 2000 - 2012

Supplier Quality Assurance Engineer

Create, Correct, Modify Incoming Inspection Procedures

Interface with New Product Engineering on Critical Features for Quality Issues

Review ECO’s for accuracy prior to creating Inspection Procedures

Instrumental in the changeover from Access to Agile for Inspection Procedures

Teaching / Training new employees the Inspection Procedures Database

Responsible for 40 Suppliers who manufacture for DePuy Spine

Conducted on-site annual audits at suppliers facilities

Reviewed all Corrective Action responses from suppliers for accuracy and follow up audit if required,

Approval of purchasing selection of new suppliers and on-site audit to verify

Pararmax Eagan, Minnesota 1999- 2000

Quality Assurance Engineer (contract)

Raytheon Company, Portsmouth, RI 1979-1999

Quality Assurance Engineer

Managed all in process inspection for all deliverable products.

Conducted in-house training for (ESD) electrostatic discharge, policies and procedures, ISO Quality Systems, in process test and inspection documents.

Approved all finished products to the customer for sale/ship.

Reviewed all in process documents for compliance.

Coordinated customer inspections and tested products.

Instructor for in-house quality procedures.

Conducted source inspections for Raytheon in the US.

Provided liaison between Raytheon and various customers.

Selected to investigate problems in manufacturing.

Appointed to a 5-year term as Chairman of the Product Assurance Council of Raytheon at Corporate Headquarters.

Auditor of Raytheon Portsmouth Facility and Corporate

Received awards from Raytheon Corporate for work completed on the Product Assurance Council.

Selected by various customers to be their representative at Raytheon for all quality issues.

Selected by various customers to perform all source inspections through out the US for them.

Assigned to other Raytheon Facilities to Coordinate and Investigate problem areas and recommend any necessary changes as needed.

Assigned to Hoffman Laroche Pharmaceuticals for all Quality Assurance disciplines including all vendor source inspections for two years

ISO 9000 Qualification Team Member and Corporate Auditor

Performed all artwork source inspections at vendors for printed wiring boards and multi layer boards.

Appointed as liaison for Raytheon with various subcontractors combined with for government contracts.

Managed a staff of twenty inspection technicians for all daily activities

DOD Secret Clearance

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MANUEL PERRY JR.

PO Box 582

Portsmouth, RI 02871

Cell 401-***-****

EDUCATION

University of Rhode Island, North Kingstown, RI

Business/Engineering BS Degree

Bristol Community College, Fall River, MA

Associate Degree Business

TRAINING

Graduate of Raytheon in-house Schools

Performing of Audits Internal and External

Quality Assurance Requirements

Planning & Scheduling

Policies & Procedures

Government Inspection Documents

Testing & Delivery of Products

Writing Quality Assurance Plans

Performing Customer Service Inspections

Vendor Validation Surveys and Audits

Handling an FDA Audit

Understanding the Japanese Medical Device Market

FMEA Analysis

ISO 13485: 2003 Lead Auditor/ Internal Auditor

ISO 9001:2000 Internal Quality System Auditor

GMP/QS Requirements and Industry Practice

Leadership Effectiveness and Development

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