We are seeking a highly motivated and experienced Quality Assurance Manager with a proven track record of establishing and implementing quality management systems compliant with ISO 13485:2016 and successful first time and continued ISO certification. This position will be reporting to the Vice President of Product Development.

PRIMARY RESPONSIBILITIES:

  • Implement a QMS compliant with ISO 13485:2016 – finalize and release documentation, oversee building of records, prepare for and conduct internal audits, prepare for registration audit and receive first-time ISO 13485:2016 certification
  • Maintenance of ISO 13485:2016 QMS and alignment of QMS to meet the requirements of US FDA (21CFR 820) and other applicable quality and regulatory standards

QUALIFICATIONS:

  • M.S. degree in Quality Assurance or established record of QMS experience
  • Successful track record of first-time ISO certifications
  • Familiarity with FDA’s Quality System Regulation for IVD devices
  • ISO auditor certification desirable
  • Project Management experience desirable
  • Experience with global regulatory authorities (e.g. CE, PMDA, ANVISA) a plus

KNOWLEDGE, SKILLS, AND ABILITIES:

  • Provides guidance, leadership and direction in developing and maintaining a best-in-class QMS
  • Attend project meetings providing development quality input, leading resolution of quality-related issues
  • Supports preparation, coordination, and management of documents in response to inquiries by regulatory agencies
  • Proven project management skills, contract management experience a plus
  • Strong QMS and regulatory knowledge; organized and efficient
  • Proven interpersonal, communication, and presentation skills
  • Ability to thrive in a fast-paced, evolving environment; able to manage competing priorities

SALARY AND CLASSIFICATION:

  • Classification: Full-time position
  • Compensation: Competitive and commensurate with experience; includes equity package
  • Benefits: Medical, dental, and vision; 401(k) and more

HOW TO APPLY: Please forward a cover letter and resume to: jobs [at] inflammatix [dot] com