Coordinator - Quality Assurance & Regulatory Compliance

Orchid Orthopedics Lansing , MI 48933

Posted 2 weeks ago

SUMMARY OF POSITION

The Coordinator, Quality Assurance & Regulatory Compliance maintains the Quality Management System (QMS) and ensures training is performed and recorded as required and serves as a backup resource to the Regulatory Team.

KEY JOB RESPONSIBILITIES
  • Acts as site administrator for the QMS
  • Ensures documents in the QMS are up to date and reviewed at regular intervals
  • Collaborates with Orchid sites to establish QMS best practices and continuous improvement
  • Processes and reviews document creation/change requests
  • Assists document owners with writing, editing and training of new and revised procedures
  • Assists with setting up, tracking and recording training events
  • Verifies employee training is current and complete
  • Provides QMS training to employees
  • Assists with CAPAs and audit findings related to the QMS
  • Assist the Regulatory team as needed
  • Comply with all Quality Management System (QMS) Documentation and ensure it is complete and accurate
  • Performs other work as assigned
EXPERIENCE
  • Proficient with databases and web based applications
  • Working knowledge of ISO 13485 and/or FDA 21 CFR 820 Subpart D preferred
  • Prior experience creating or modifying controlled documents
  • Work experience in a previous quality-related position
  • Preferred experience with SQL programming and report generation in database and web based environments
KNOWLEDGE, SKILLS AND ABILITIES
  • Working knowledge of ISO 13485 and FDA 21 CFR 820 Subpart D
  • Excellent analytical and computer skills
  • Must be proficient in Excel, Word, PowerPoint and Adobe
  • Excellent organizational skills
  • Attention to detail
  • Ability to teach others
  • Must work well with others - collaborative
EDUCATION AND CERTIFICATION
  • High School diploma required
  • Associate’s degree preferred
ABOUT OUR VALUES

As a member of our team, leading from our values is foundational.

Values:

  • Integrity First: We Do the Right Thing
  • Teamwork: We Are All Connected
  • Relentless Pursuit: We Are Driven & Curious

If you are interested in applying for this position, please send your resume to: recruiting@orchid-ortho.com

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Coordinator - Quality Assurance & Regulatory Compliance

Orchid Orthopedics