Director, Quality Assurance and Regulatory Affairs

 

Director, Quality Assurance and Regulatory Affairs

 

 

North American Science Associates, Inc. (NAMSA), a World Leader in the testing of medical devices for over 40 years, has an opportunity for an experienced quality assurance and regulatory affairs professional.

 

Responsibilities for this position would include:

 Plans, directs, and coordinates QA program activities at all NAMSA locations. 

§ Management representative for ISO 13485 and ISO 17025 standards.  Shared interface with the FDA for regulatory audits and submissions. Selects, trains, and supervises staff to perform quality assurance functions consistent with strategic plans for ongoing implementation of the NAMSA Quality Policy.  Act as Management Representative for the corporation with respect to ISO 13485 and ISO 17025 standards, ensuring compliance with the requirements of these and pertinent quality standards (FDA, GLP, GMP.) Works with managers to design and implement programs to improve overall quality and increase regulatory compliance.Develops programs assuring test validation and audits (internal, external, check sample, regulatory) accurately assess ongoing performance and detect quality problems.  Assures effective CAPA program.

 

The position requires a minimum of a bachelor’s degree in a scientific discipline.  Eight years related experience required, including 5 years of supervisory experience. 

 

NAMSA provides a competitive salary with bonus program as well as a comprehensive benefits package including health, life, dental, prescription drug card, 401k /profit sharing, and tuition assistance.  Candidates may send a resume along with salary history to our corporate offices:  NAMSA, 6750 Wales Road, Northwood, OH, 43619; fax 419.666.2954; email edickman@Namsa.com