Co-ordination of workflow and prioritization including capture of relevant metrics. Additionally Quality systems support to Quality Engineering and assistance with appropriate continuous improvement activities
- Authority Assignment:
During periods of absence, the Quality and Regulatory Affairs Director shall ensure that all the responsibilities of this position are appropriately assigned.
- Responsible for the Q Pulse record management system (the computerized quality system tracking tool). This includes development and improvement projects, as appropriate.
- Responsible for the document control system including co-ordination of DCR process and ongoing compliance.
- Will generate reports for data trending and analysis of the quality system (as required).
- Will handle all administrative activities to support Document Control and Quality Records Storage including trending reports and tracking activities to assure compliance and in line with identified timelines.
- May assist or perform internal audits and assist in preparation for external audits, as required.
- Other quality system projects as necessary.
- Certificate/Diploma in Quality Assurance or equivalent industrial experience within the medical device industry, of which at least two years must be within a quality assurance or related role.
• Excellent verbal and written communication skills.
• Excellent attention to detail skills.
- Specific Requirements:
- Ability to work within a team environment to achieve agreed company goals.
- Ability to communicate effectively with all levels of the company.
- Ability to meet deadlines.
- Good understanding of ISO 13485 and FDA QSR quality standards.
- Proficiency in use of desktop software applications such as MS Office
- Environmental Conditions:
Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.