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QA Manager - Medical Device

QA Manager - Medical Device

Job Description

SUMMARY OF POSITION
 

Medpace, a rapidly growing global Contract Research Organization is seeking a Quality Assurance Manager for Medpace Medical Device, based in Blaine, Minnesota. This position will focus primarily on Medical Device clinical trials conducted by Medpace Medical Device (MMD). This position will report directly to the Executive Director, Quality Assurance.
 

DESCRIPTION OF JOB DUTIES
 

  • Coordinating and conducting internal project-level, process and system audits for MMD operations and supporting functions;

  • Hosting audits by Sponsors and Regulatory Inspectors of Medpace MMD; providing internal support and guidance on outcomes

  • Coordinating, conducting, and tracking Regulatory Training (ICH/GCP, ISO);

  • Involvement on the Medpace QA Management in development and execution of strategic and tactical objectives focusing on continuous improvement of the Medpace Quality System and QA Operations;

  • Providing guidance and oversight of the Medpace CAPA program working with outside clients/sponsors; and

  • Other items as deemed necessary.

Job Requirements

QUALIFICATIONS/REQUIREMENTS
 

  • Candidate must have a BA/BS (or a BSN) in Life Sciences;

  • 3 - 5 years of experience in a QA department in a related industry required;

  • Medical Device experience is required;

  • Knowledge and application of GCP is required;

  • Past supervisory experience is preferred;

  • Experience in conducting audits of device clinical trials, critical vendor assessments (e.g., IRB, Archiving, Clinical Labs); and thorough knowledge of Medical Device QMS requirements and QSIT

  • Experience in hosting Regulatory Authorities and interacting with Sponsor/client representatives;

  • Independent thinking and planning ability;

  • Excellent written and verbal communication skills; and

  • Good teamwork skills, as well as the ability to work independently.

 

Travel: Up to 30%
 

WHY MEDPACE?
 

Finding work that is challenging, where you are given the tools and training to succeed, where you are rewarded and are provided opportunities to grow professionally are just a few reasons talented individuals join the Medpace team.
 

WHAT TO EXPECT NEXT
 

We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.
 

EO/AA Employer M/F/Disability/Vets

Job Snapshot

Employment Type Full-Time
Job Type Pharmaceutical, QA - Quality Control
Education Not Specified
Experience Not Specified
Manages Others Yes
Industry Medical Equipment
Required Travel Up to 25%
Job ID US-MN-QAM
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QA Manager - Medical Device


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