About Us
Surgical Innovations Ltd, a leading UK manufacturer of medical devices, is seeking a highly skilled Quality Assurance Specialist to join our team. With over 30 years of experience in designing, developing, and manufacturing high-quality instruments for minimally invasive surgery, we are committed to delivering sustainable and innovative solutions that advance healthcare.
As a key member of our Quality Assurance team, you will be responsible for ensuring the quality and compliance of our medical devices, working closely with our Manufacturing, Quality Control, and Purchasing teams to meet planned demands.
Key Responsibilities
* Manage day-to-day quality assurance activities, including document and change controls, CAPA/NCRs, concessions, and customer complaints.
* Prioritise workloads and throughput to meet business demands.
* Facilitate and uphold the correct application and completion of all quality documentation generated through the business.
* Complete final batch release process to meet sales demands.
* Troubleshoot and resolve quality-related internal enquiries and issues within the business.
* Participate in external third-party audits, acting as QMS SME.
* Complete trend analysis, reporting, and presenting of Quality data at all levels and specifically for management review.
* Assist in the routine generation of trend analysis and quality data reports and metrics.
* Support the maintenance and development of the QMS to reach compliance with current standards and regulations.
* Carry out internal audits to meet the agreed schedule.
* Develop, improve, and write new processes and SOPs as required.
* Lead on assigned projects to improve quality and regulatory compliance.
* Assist with regulatory activities where required.
* Provide QMS-related training to support and improve compliance to current standards and regulations.
Requirements
* Minimum 3 years' experience in Quality Assurance, working to the requirements for international quality systems for a medical device company, including ISO 13485.
* Working knowledge of EU Medical Device Regulation, MDSAP country-specific regulations, including FDA regulations (21 CFR 820), Canadian Medical Device Regulations, and other international regulations.
* Effective communicator with good interpersonal skills and the ability to work in a cross-functional team.
* Strong organisational skills with a keen eye for detail and ability to manage documentation.
* Good problem-solving ability and commercial awareness.
* Customer-oriented/focused and able to develop and maintain good customer relationships.
What We Offer
* A competitive salary of up to £33,000.
* A range of benefits, including 9-day working fortnight, flexi-time, pension, life assurance, income protection, health cash plan, and high-street discount scheme.