Quality Assurance Director:|
Bioresource Technology, Inc., a leader in human plasma and serum processing for in vitro diagnostic products and a manufacturer of clinical chemistry controls is seeking a Director of Quality Assurance in its headquarters in Miramar Florida. Essential duties will include responsibility for ensuring that the quality system requirements are established and maintained in accordance with Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) requirements and for training company employees in quality practices.
The successful candidate will have the following qualifications:
- Master's degree (M. A.) or equivalent in a scientific or quality discipline; or four to ten years related experience and/or training in quality assurance in the medical device manufacturing industry or similar biotechnology industry; or equivalent combination of education and experience.
- Must be familiar with FDA Medical Device regulations including 510k submissions as well as ISO 13485, Canadian CMDCAS regulations, and EU CE mark.
- Ability to write reports, documents, standard operating procedures, protocols and procedure manuals, corrective and preventative action plans, responses to customer inquiries or complaints, regulatory agency audits, , and questions from suppliers and international clients.
- Ability to perform internal and external audits.
- Ability to establish document control system for control of procedures, manufacturing documents, and work instructions.
- Key contact for all audits as well as responsibility for replying as needed.
- Must have a practical and hands on approach.
- 401K Match
- Bonus Plan
- Health Insurance
- Competitive Salary