Director - Quality Assurance and Regulatory Affairs

Director of Quality Assurance – Regulatory Affairs

Our client, a highly rated medical products manufacturer is currently seeking a Director of Quality Assurance and Regulatory Affairs.  This individual will be responsible for the design, implementation and maintenance of policies and procedures to ensure that quality standards are met during production.  This includes working with the Production Manager to ensure all products meet established quality standards, comply with all government regulations, and are OSHA compliant.  In addition, the Director of Quality Assurance will provide the needed support to production, sales, and R&D to help them meet their objectives.

RESPONSIBILITIES:

§  Manage, direct, control, maintain and update  regulatory requirements for both medical devices and pharmaceuticals with a focus on results and compliance.  Liaison with appropriate regulatory control agencies.

§  Ensure compliance with all regulatory requirements and ensure that all products are produced within the established quality standards for products.

§  Create, revise and maintain Quality System to ISO 9001-2008, ISO 13485:2003, CMDR,  European Medical Device Directive, and FDA cGMP requirements.

§  Regularly audit to ensure that all procedures for testing are effective and performed as required.

§  Manage document control, maintain tracking logs, nonconformance logs, process change logs, quality plan logs, document control logs, and design control logs.

§  Manage review process of Device History Records (DHR) to ensure product is manufactured per requirements, product accountability is correct and documentation is accurate.

§  Perform internal and external audits.

§  Investigate and trend complaints.  Conduct trend analysis of nonconformances and other quality indicators.

§  Host customer and agency audits.

§  Participate in the launching of new or improved products/processes, including validation, manufacturing procedures, SOPs, in-process and final testing, risk analysis including FMEAs and ensuring all product compliance.

§  Supervise inspection personnel.

§  Manage and conduct all QSR and cGMP training, and ensure all required trainings are up to date throughout the company.

§  Maintain a safe working environment.  Insure that all employees comply with OSHA requirements and all safety procedures.

§  Lead quarterly management review of the Quality System.

§  Work in conjunction with Human Resources to pursue continuous professional development of self and direct reports.

§  Other duties as required.

EDUCATION, EXPERIENCE REQUIRED:

§  Bachelor’s degree in Engineering, Biology, or Chemistry required

§  Minimum of eight years experience with Quality Systems, five years supervisory experience

§  Preferred: Hands on experience with FDA, both people and regulations, Hands on experience with ISO and Medical Device Directive (class I and class II devices)