My client, a innovative medical device company who is currently in growth mode is seeking a Manager of Quality Compliance and Audits. The successful candidate will direct the local internal audit program at the facility, as well as, provide training and guidance for the site audit team members and site management.
- Supports site management in the development of quarterly and annual audits.
- Directs the internal auditing function and the audit team members for the implementation of regulatory and quality system effectiveness audits at the manufacturing site. Will schedule and implement plans for comprehensive annual reviews of the regulatory compliance and internal audits areas taking into consideration quality metrics, results of internal audits and external inspections, industry trends and the external regulatory environment.
- Coordinates and conducts routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards and other applicable requirements[i.e. QMS, QSIT, Combination Products, Regulatory requirements; PAL, TGA, Notified Bodies, etc.
- Provides guidance and coaching to the team
- Provides auditor training to audit team members, internal auditors and supporting auditors through formal classroom training, web based, or on-the-job training.