Description
This individual will be responsible for developing and managing the Quality Control and Quality Assurance program while assuring that the organization is in compliance with appropriate federal, state, and other applicable regulations. The VP of QA will act as the primary contact for FDA inspectors, ISO, vendor and partner auditors as well as arranging internal audits and acting as the lead auditor for both internal and external audits. This position requires expertise on CAPA and process improvement as well as being able to effectively establish and communicate strategic plans and objectives to other Executives and the stakeholders of the company.Candidate Requirements:
- Minimum 15 years of directly related experience in increasingly responsible positions in the Medical Device or Pharma industry
- Minimum 5 years Supervisory or Management experience
- Expertise in FDA, EMA and other international regulatory agencies as well as ISO; and the ability to communicate to the regulatory bodies clearly and concisely
- Must have International experience in all major markets (including the Americas and Europe)
- Experience designing and implementing quality systems and procedures and audit conduct/readiness for the medical device or biotech industry
- Six Sigma black belt training, ASQ CQM (Certified Quality Manager) or CQE (Certified Quality Engineer) is highly desirable
- A Bachelors Degree or Masters Degree. in a technical and/or scientific discipline is required
- Must be willing to travel up to 30% of the time.
If you meet the above requirements and are looking for a challenging yet rewarding opportunity with a successful and growing company, apply on-line now.