Quality Assurance Specialist

4 weeks ago

leeds west yorkshire, United Kingdom Surgical Innovations Ltd Full time

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. We place great value on our mutually respective relationships, a workplace which is collaborative and dynamic, and a culture which is inclusive and purposeful. The result; 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


Do you want to be part of an organisation that is leading the evolution in delivering sustainable and innovate solutions which advance healthcare? If so, we want to hear from committed and talented people like you, who share our vision and values, to come and join our team.


About the Position

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. You will prioritise your time to effectively contribute to departmental activities to meet planned demands.


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.


Responsibilities

On a day to day basis your new role will involve:


  • Day-to-day management of QMS (document control, change control, CAPA/NCR, concessions, supplier control, customer complaints)
  • Completion of all environmental, microbiology and routine product sterilisation / validation activities to agreed schedule.
  • Prioritise workloads and throughput to meet business demands
  • Facilitate and uphold the correct application and completion of all quality documentation generated through the business.
  • Completion of final batch release process to meet sales demands
  • Troubleshoot and resolve quality related internal enquires, 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.
  • Assists 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/regulatory compliance.
  • Assist with regulatory activities where required.
  • Provide QMS related training to support and improve compliance to current standards and regulations.


Requirements

To be successful in this role you will need to be able to demonstrate the qualifications, experience and skills for the role:


  • 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.
  • 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

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.


If this sounds interesting and the right challenge for you, we look forward to receiving your application

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