Quality Engineer Manager

Richard S Thomas

**** ****** **** **** *** B-***

Mayfield Heights, Ohio 44124

Cell 574-***-****

Email: ****************@*****.***

CAREER SUMMARY

Experienced Manager/ Lead auditor/Supplier management/Quality engineer with experience Spinal / Orthopedic Implants & instrumentation, Dietary supplements, Imaging and internal/supplier audits. Dealt with engineering, quality control, and production management of orthopedic implants and instruments. Knowledgeable professional with the proven ability to impact business operations and improve product quality. Fluent in ISO 13485, 21cFR210, 211part820, cFR111, Trackwise and Agile. Dietary Supplements. Trained employees on internal policies and FDA standards.

EXPERIENCE

Philips Medical Sept. 2014 to Dec. 2018

Quality Engineer

Providing oversight of Q&R Manufacturing NPI (New Product Introduction) projects ensuring timely completion of project deliverables, correcting issues delaying completion and reporting on quality system status of projects on manufacturing department or site level.

Working on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Following processes and operational policies in selecting methods and techniques for obtaining solutions.

Taking a leadership role, with responsibility to perform root-cause investigations associated with identified Corrective Action/Preventive Action (CAPA), (SCARS).

Living Essentials May 2011 to Jan 2013

Supplier Management

Provide guidance to the organization to ensure continuous quality improvement through the facilitation and development of applicable policies, practices and procedures.

Responsibility for developing audit schedule Internal/Supplier, audit plans and writing audit reports and documents non conformances and reporting them in the Corrective Action System.

Evaluate new suppliers and work with suppliers monthly to review their supplier score card.

Set up complete supplier management program.

Maintain correspondence with outside suppliers

Medtronic Sofamor Danek June 1999 to March 2011

Quality Lead Auditor

Quality Systems/Lead Auditor Sept. 2006 to March 2011

Provide guidance to the organization based upon external and internal audit results to ensure continuous quality improvement through the facilitation and development of applicable policies, practices and procedures.

Responsibility for developing audit schedule, audit plans and writing audit reports, selecting and evaluating documents Non conformances and reporting them in the Corrective Action System. RABQSA Certified Lead Auditor

Metrology Supervisor Jan 2001 to Sept 2006

Supervise work performance and department activities of the Quality Metrology lab and Quality Systems Document Control. Including First Article of product, Gage Calibration program and Engineering Documentation Control Room. Responsible for hiring, terminations, performance appraisals, and position descriptions.

Recommend measures to improve gaging methods, equipment performance and quality of product.

Maintain correspondence with outside suppliers.

Write and justify expenditures and Investment Request for new equipment.

Monitor monthly calibration cycles.

Responsible for all aspects of raw material.

Develops and administer budgets.

Development and deliver training to employees at all level.

Responsible for First Articles and gage R&R

Medtronic Sofamor Danek Quality Supervisor June 1999 to Jan 2001

Supervise work performance and department activities of quality inspectors, packagers.

Review reports and confer with quality assurance, production, and management personnel to solve work-related problems.

Recommend measures to improve production methods, equipment performance and quality of product.

Provide training to new and existing employees.

Assist staff with responsibilities and delegate tasks commensurate with skill level.

Responsible for hiring, terminations, performance appraisals, and position descriptions.

Monitor weekly manpower and adjust manpower with temporary employees.

Maintain correspondence with outside suppliers regarding quality issues.

Zimmer Inc., Division of Bristol Myers Squib Graphics Supervisor Warsaw, Indian

September1969 to September 1997

Education & Skills

Warsaw Community High School Warsaw, Indiana

Ivy Technical Institute Warsaw, Indiana, IPFW Fort Wayne Indiana

Instructed Technical Graphics Communications/Manual Drafting/GD&T

Affiliation

Warsaw Lodge73

Fort Wayne Mizpah Shrine Temple.

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