About us For over 30 years, Surgical Innovations have proudly designed, developed and manufactured high quality, precision engineered instruments for minimally invasive surgery and are a leading UK manufacturer of medical devices in its respective field.
Our success is our people and we currently employ over 100 staff from our head office in Leeds. a platform for individual development, growth, and prosperity.
As we seek to identify, nurture, and retain talent, we offer competitive benefits packages, continuous training and development opportunities to ensure those joining us on our journey, grow too!
As Quality Assurance Specialist you will be responsible for the day-to-day quality assurance activities of the business, including document and change controls, CAPA/NCR's, concessions and customer complaints. This role will work collaboratively with the Manufacturing, Quality Control and Purchasing teams within the business to ensure product is released on time and to the correct standards.
Day-to-day management of QMS (document control, change control, CAPA/NCR, concessions, supplier control, customer complaints)
Facilitate and uphold the correct application and completion of all quality documentation generated through the business.
Troubleshoot and resolve quality related internal enquires, and issues within the business
Complete trend analysis, reporting and presenting of Quality data at all levels and specifically for management review.
Assists in the routine generation of trend analysis and quality data reports and metrics.
Lead on assigned projects to improve quality/regulatory compliance.
Assist with regulatory activities where required.
Provide QMS related training to support and improve compliance to current standards and regulations.
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 - desirable.
Good problem-solving ability and commercial awareness
This position offers a competitive salary of up to £33,000, accompanied by a range of benefits including 9 day working fortnight, flexi time, pension, life assurance, income protection, health cash plan, and high street discount scheme.