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Principal Clinical Quality Auditor in Arden Hills, MN at APEX Systems

Date Posted: 2/11/2019

Job Snapshot

Job Description

Job #:  928579

Principal Clinical Quality Auditor 

The Principal Clinical Quality Assurance Specialist position supports the internal clinical quality assurance program and quality systems for class III medical devices. This includes clinical compliance, quality audits, Inspection Readiness program, and, supporting clinical Corrective and Preventative Action (CAPA) and acquisition integration.

Your Responsibilities:

  • Support and mentors the Clinical organization in meeting Quality system requirements
  • Review, revise, update and maintain Clinical approved vendor list and manages updates to the clinical vendor audit database.
  • Plans, schedules, and conducts external quality assurance audits of the clinical vendors employed in the design, conduct, and analysis of clinical trials.
  • Supports the CAPA process, working cooperatively with Clinical owners providing quality input
  • Contributes to the development and or review of clinical and clinical quality procedures and processes
  • Assists Clinical Quality Assurance Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.

Basic Qualifications:

  • Bachelor’s degree in Life Sciences and 6 years of experience or Master’s degree and 4-7 years of experience
  • Minimum 6 years’ experience of clinical QA experience in the medical device industry
  • Minimum 3 years direct clinical quality (GCP) auditing experience
  • Travel up to 50% can be expected

 

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178