The Quality System Manager is responsible for managing the processes and people within the Quality Systems dept to ensure that the company is in compliance with all applicable regulatory and business requirements.
- Manage the Quality System team and ensure that both regulatory and business requirements are met in the daily running of the department. This includes motivation, training, and appraisal of QS staff.
- Responsible for processes within Document Control training, Customer Quality, and Master Data area.
- To take a leadership role in driving improvement initiatives in the Quality Management system across the site.
- Drive and enhance a compliance culture though-out the site.
- Providing Quality Systems support for all business units and sites.
- Preparing for and supporting external audits (TUV, FDA, customer etc).
- Ensure adequate monitoring and measurement of processes, and reporting the same to management.
- Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organization.
- Be responsible for Health & Safety within assigned areas.
- Manage the plants quality system ensuring it's in agreement with all regulatory compliances.
- Any other duties assigned from time to time.
- Level 8 degree in Quality Assurance or Degree in Science / Engineering with an additional qualification in Quality Assurance.
- Experienced Quality Systems Manager with a minimum of 3 years experience within the Medical Device or related industry.
- Excellent working knowledge and proven track record in all aspects of ISO13485 and FDA QSR requirements.
- Regulatory experience / knowledge.
- Good organization, supervisory, technical writing and investigation skills are required.
- Excellent communication and interpersonal skills.
- Proven ability to influence.
- Building Effective Teams
- Motivating Others
- Managing and Measuring Work
- Values: Integrity, Accountability,Teamwork, Innovation
- SET : Strategy, Execution, Talent (for managers)