Description
Job DescriptionSr. Compliance Specialist:
* 5 to 7 years experience in the medical device industry in quality assurance or compliance, or a combination of quality assurance and operations. Thorough knowledge of GMP and Quality Systems required.
* Certified Auditor qualification or ability to attain certification (ISO 13485 or other similar certification for the Medical Device industry)
* Strong organization and project management skills
* Ability to work well in a team environment at multiple levels
* Ability to influence others
* Strong interpersonal relationship skills
* Responsible for developing, implementing and managing appropriate quality systems and practices to ensure that the Site is in substantially compliance to the Quality Manual and all relevant regulatory and notified body requirements.
* Ensure high level of compliance to FDA QSR/cGMPs and ISO 13485 in all assigned areas.
* Demonstrate a primary commitment to patient safety, product quality and compliance with the Quality Manual and its governing regulations.
* Ensures internal and selected supplier compliance audits are conducted in accordance with established guidelines
* Coordinates training in GMPs and Quality System awareness
* Develops and continuously improves Quality Systems at the site level to comply with corporate requirements and site needs
* Lead CAPA Board and coordinate CAPA activities.
* Ensures compliance with company quality assurance policies and practices.
* Maintains the CAPA and Internal Audit schedules and files and provides metrics on company performance to Quality objectives.
* Is a key participant in audits performed by regulatory bodies (FDA, Notified Body) and Corporate Compliance group.
* Communicates with regulatory agencies, at the direction of Management Representative, on selected regulatory compliance issues and regulatory agency audits and inspections.
* Coordinates Management Reviews and data preparation
* Performs responsibilities required by the Quality System and other duties as assigned or requested
If interested please forward me a copy of your resume and I will be in touch shortly.
Thanks!
To find out more about Real please visit www.realstaffing.com