An opportunity has arisen within the Quality Department for a Group Quality Process Manager. The role will report to the QA/RA Director.
The Group Quality Process Manager is an experienced person within the medical device industry with extensive knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulations (QSRs), International Organization of Standardization (ISO) 13485:2016, Medical Device Directive (MDD) 93/42/EEC, and new Medical Device Regulations in EU, ISO 14971:2007. The incumbent has the ability to take strategic direction and establish consistent, efficient and compliant processes throughout the organization and has strong communication at all levels. This position is to manage set up standard processes for the Quality team across the business to utilise to ensure compliance and efficiency.
Key Results Area:
- To work with the country Quality Managers to standardise and improve the Quality Management System (QMS) processes across the AMS Network
- To set-up and manage the group function in Quality
The ideal candidate will have:
- Bachelor’s Degree with a minimum of 10 years experience in the medical device industry
- Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents
- Good commercial and business acumen, leading to pragmatic solutions
- Excellent verbal and written communication skills
- Effective problem solving skills, experience on advanced quality tools, lean manufacturing and 6-sigma program is preferred
- Ability to work in a team minded approach to achieve individual and company success