International group of companies, providing innovation within the medical device field to improve patient mobility and accessibility. With manufacturing sites located throughout the UK and Europe, and sales functions globally, they hold a strong market share, with further growth plans.
As Quality Specialist, you will monitor, analyse, and report on company quality performance and drive improvements to maximise efficiencies and quality. Maintain or achieve business compliance with applicable regulations and standards.
Reporting to the Head of Quality, you will be:
- Responsible for ensuring business activities, Quality Systems, and documentation are conducted in compliance with the regulations and standards applicable to ISO 9001 and ISO 1384
- Ensuring, that all required accreditations are maintained and obtained.
- Monitor, analyse and report on the businesses and its supplier's quality performance to highlight trends, issues, opportunities, and drive identified improvements.
- Maximise quality through extensive analysis of the business to identify opportunities to streamline and improve processes, products, systems and to eliminate waste.
- To drive defined improvement projects
- Develop, maintain, and execute a business wide Audit program designed to focus on weaknesses, drive opportunities and achieve compliance.
- Manage, execute, and report on the CAPAs, waste and the customer complaints.
- Attend and lead on any Quality and Audit meetings and resulting actions
- Input to Group wide QA system and revise and/or formulate required local business policies, SOPs, Work Instructions and promote their implementation & use. Requirements:
- A full understanding of ISO 9001 & ISO 13485
- Experience in managing and leading in 3rd party audits
- Ideally, experienced in a Quality Management position
- Significant experience in Quality and ideally in a clinician delivery organisation
- In-depth knowledge of diverse business functions and principles (e.g. supply chain, clinical services, customer service, etc.)
- Working knowledge of data analysis and performance/operation metrics
For more information, or to discuss your career in the Medical Device arena, please contact Holly Evans on firstname.lastname@example.org
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