Job Description
Exciting new opportunity: A growing Medical Device company are looking to add a Quality Manager to their team based in Hertfordshire. This role will be worked on site 5 days a week and are offering a salary of up to £65,000.
Responsibilities include:
* Maintain the Quality Management System by recording incidents, implementing corrective actions and tracking improvements.
* Conduct audits of the internal systems to ensure compliance with ISO 13485.
* Lead external quality assurance audits when required.
* Identify, document and investigate non-conformances, determine root causes, and track resolutions in weekly meetings.
* Monitor the production cycle, performing regular tests to detect issues early in the process.
* Inspect product materials and test finished goods to ensure they meet specifications.
* Lead the transition to automated test equipment for quality testing, minimizing manual testing by operators.
* Review production Work Instructions (WIs) to ensure they are completed accurately and comply with standards.
* Oversee the quality department by setting clear job expectations, planning and monitoring team performance, and appraising results.
Knowledge, skills and abilities:
* Minimum of 5 years experince in a similar supervisory or multi-functional role.
* Strong understanding of quality standards, including ISO 13485, UKCA, and MDR.
* Background in working within ISO quality systems (such as ISO 9001 or 13485), with preference for medical device industry.
* Internal auditor certification in ISO 9001 or 13485 is a plus.
* Self-driven with the ability to work independently and effectively manage tasks.
Please apply to this job posting with your resume attached and I will give you a call!