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Medical Device Quality/Regulatory Management Leader

Location:
Germantown, TN
Posted:
April 23, 2020

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Resume:

Robert Churinetz

Quality Assurance Specialist

adcxln@r.postjobfree.com

901-***-****

**** ******** ** * **********, TN,

38139

EDUCATION

THE UNIVERSITY OF BRIDGEPORT

Bridgeport, CT

Completed coursework towards BS

Biology (Sep 1985)

ADDITIONAL SKILLS

Business Level Speaking

FDA interaction

Surgeon Interaction

Workforce Motivation

Expertise in International Regulatory

Affairs

LICENSES AND

CERTIFICATIONS

CERT certified

Germantown CPD Certified

CAREER OBJECTIVE

Proactive professional with 30+ years of experience and a proven knowledge of cost avoidance, efficiency improvement, and just-in-time. Aiming to leverage my skills to successfully fill the Quality Assurance Specialist role at your company. PROFESSIONAL EXPERIENCE

OWNER

Agency Consulting, Germantown, TN / Jul 2013 – Present

Guidance for Medical Device Manufacturers

Analyze operations to evaluate performance of a

company or its staff in meeting objectives or to determine areas of potential cost reduction, program improvement, or policy change.

Confer with board members, organization officials, or staff members to discuss issues, coordinate activities, or resolve problems.

Interpret and explain policies, rules, regulations, or laws to organizations, government or corporate officials, or individuals.

VP

The Woundcare Co. LLC, Memphis, TN / Aug 2005 – Jul 2013

Achieved product clearance from Taiwan/China FDA

Constructed and implemented FDA and international Compliance

Delivered qualified vendor to produce cost-saving manufacture of products

VP

Wright Medical Technologies, INC, Arlington, TN / Jul 1993 – Jul 2004

Obtained over 150 FDA market clearances to market

Managed with a Quality First attitude resulting in zero recalls.

Introduced and implemented Lean Manufacturing



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