To support participation and maintenance of the Elekta Inc. Quality Management System (QMS) for Xoft products to meet identified standards, regulations and company requirements
Requirements
- QA Engineering skills and knowledge in a certified CE, ISO 13485 and MDSAP medical device industry company
- Expert knowledge of ISO 13485, MDSAP, CE and other global quality system standards and regulations
- Proficient in Microsoft Office and computer applications to perform role
- A university technical degree or equivalent and/or a number of years' experience in Medical Device Quality Assurance desired
Responsibilities
- Perform QMS duties such as document control, complaint handling, corrective/preventive action, nonconformance management, internal audits, support/host external audits, support product design projects, support RA, and escalation to upper management
- Maintain procedures, work instructions and templates in the Elekta Inc. QMS
- Quality Records management of the Elekta Inc. QMS
- Implement any new Quality requirements into the Elekta Inc. QMS
- Identify and implement process improvements in the Elekta Inc. QMS
- Report status and issue escalation to upper Management as required
- Manage and/or participate in Elekta Inc. QMS internal and external audits
Other
- Minimum of 3 years in a medical device industry or regulated manufacturing facility Senior QA position is required
- Ability plan, host and manage Quality meetings
- A structured approach to problem solving with an appreciation of quality tools & techniques
- Excellent English written and verbal communication skills are essential
- Ability to work efficiently within a multi-cultural environment
