Quality Assurance Executive

at  TensCare Ltd

TensCare Ltd are an Employee Owned company where every team member has a say in how the company is run. We have evolved over the last 30 years to become Europe’s largest distributor of TENS machines and sell a wide range of electrotherapy pain relief and muscle rehabilitation units.
Have you worked in Quality Assurance or Regulatory Affairs for a Medical Device company? Then get in touch with us.
We are looking to add to our team a Quality Assurance Executive who is passionate, driven, confident and commercially minded. It is a full-time position and will be based in our busy office in Epsom, Surrey, currently working 3 days in office, 2 from home – early on boarding MAY require more in office days initially but we will always look to be flexible.

EDUCATION AND EXPERIENCE

· Ideally 2 plus years experience in quality and / or regulatory affairs ideally in the medical device industry.
· Because the role requires a good understanding of both the engineering and physiological principles of operation of the devices, a technical degree is preferable and some physiological grounding (such as Biomedical Sciences) would be desirable.
· Bachelor’s degree in technical subject preferred: biology and life sciences, electronic and electrical engineering, physics, mechanical engineering, health science.
· Experience working on technical documents under MDR would be very desirable.
· Auditor certificate would be very desirable.

• Contributing into the Quality and Regulatory Affairs department at TensCare.
• Maintaining Quality Management System certification to EN13485 - this requires you to acquire a detailed knowledge of how the company systems operate through close cooperation with other members of the team, and to suggest ways of improving/streamlining them, including reviewing and maintaining records on our Electronic Quality Management System
• Set up and execute internal audits as directed by our Quality Management. Support on-site audits conducted by external providers.
• Evaluate audit findings and implement appropriate corrective actions.
• Provide information for Management Review meetings.
• Maintaining CE Marking certification including maintaining product EU MDR technical files and managing audits from our Notified Body.
• Obtaining and maintaining international production registration including USA FDA, Health Canada, TGA Australia, ANVISA Brazil.
• Keeping up to date with changing regulations.
• Participating in Product Development evaluation and planning (Tenscare does not currently manufacture in-house, but give detailed marketing product development specifications to contractors and evaluate new product designs). Maintaining product modification records will be important
• Working closely with suppliers to ensure ongoing compliance.
• Training internal staff on our QA procedures – familiarity with Quality Assurance management software will be a distinct advantage
  Personal requirements