Quality Audit Manager, QMS Trainer role in a medical technology company. Oversee QMS evaluation, lead QMS training development and delivery. Develop and maintain oversight practices, create QMS training materials. Coordinate external audits, define best practices and records.
**Key Responsibilities:**
* Leadership and oversight on Audit functions
* Defining, improving, and executing our Internal and External Auditing practices
* Direct Internal Audits
* Define and implement best-in-class external auditing practices and systems
* Define and implement an effective QMS Training process for all employees
* Develop training material content and delivery methods
* Offers proficient level guidance and direction of the Auditing and Training Bodies of Knowledge
* Proactively assure compliance to all applicable internal, domestic and international quality regulations
* Creates an inclusive learning environment with the Auditing and Training Team
* Represent the Auditing and Training Function in Management Review
* Maintain evidence-based Quality Metrics and define and execute activities to meet these metrics
**Requirements:**
* BSc in Bioscience, engineering or equivalent
* 4+ years' experience within quality in the medical device industry
* Experience working with Class II or III devices
* Domestic and International regulatory requirements
* Ability and willingness to travel
* Strong project management skills
* Six Sigma qualification is highly desirable
The ideal candidate will have a strong background in quality management, auditing, and training. Strong project management skills and ability to travel are required. Six Sigma qualification is highly desirable.