Quality Assurance Executive

3 months ago

London, United Kingdom Hire Recruiter Full time

**Quality Assurance and Regulatory Affairs Executive | Epsom | Hybrid working options - 3 days in office 2 days WFH | Monday to Friday | Flexible working hours between 8am-6pm | £23,000 to £27,500 dependent upon experience**

We 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.

We wish to recruit a Quality Assurance and Regulatory Affairs Associate to join our TensCare QARA team. A graduate with related qualifications (ideally bioscience/engineering) and a keen interest or ideally one or two years experience of hands-on Quality Assurance involvement or Regulatory Compliance in medical devices.

You will be a self-motivated individual, eager to take on this varied role which will involve working with and across all internal departments. You will bring your positive attitude toward change, and be confident in contributing to new ideas and improved ways of working.

**What can we give to you?**
- Bonus scheme - as an Employee Owned business all employees benefit from the majority of the shares being held in an Employee Owned Trust from which an annual dividend is paid to employees (profit dependent)
- We also have a monthly employee owner commission structure
- Private medical Insurance
- Company-wide social events
- 5% company matched pension contribution

**Are you the right person for us?**
- BSc in a relevant Scientific discipline
- Fluent in the English Language. Excellent oral, written, cross functional and interpersonal communication skills that are appropriate for various levels, including management, staff, contractors and clients
- Right to work in the United Kingdom without sponsorship.

The ideal qualifications we are looking for are listed below - however, training will be given
- Recognised qualification from a relevant quality institute / relevant experience in the medical industry
- Understanding of auditing of ISO 13485 QMS (internal and externally)/ Qualified quality systems auditor ideally certified by an IRCA registered training provider
- Good understanding of ISO13485 and CE Marking

**Your role will include but not be limited to**
- Contribute to and refine procedures, instructions, templates, and our quality manual to maintain our ISO 13485:2016 certificate.
- Work with our QARA team and Notified Body to maintain current certifications and achieve award of a CE mark and FDA approval on new products
- Provide QA team resource for the day-to-day administrative requirements to maintain and monitor the quality management system
- Prepare and maintain regulatory files such as MDR Technical Files
- Review of process/product changes, labelling, claims, product complaints, A&Ps (Advertising & Promotional materials), etc., to determine the need for any regulatory activities and to ensure compliance to International regulatory requirements
- In time with familiarity and training perform internal audits to assess the company compliance with our Quality Management System. Attend to audits performed by internal team members and external authorities to represent our QA/ RA positions and processes
- Build knowledge and maintain surveillance of the many relevant quality standards. Keep up-to-date with changes in regulatory legislation and guidelines
- Provide technical support and resolve quality issues with suppliers, customers or auditors including the introduction of new or re-designed components and processes
- Support TensCare Quality Associates and work closely with our Regulatory Affairs Manager, TensCare Leadership Management team, Product Design Manager and Supply Chain Manager
- Uphold company mission and values through accountability, innovation, integrity, quality, caring, cooperation and encouragement
- Support and comply with the company’s Quality Management System policies and procedures.
- Participate in cross-functional product development teams to understand and help the development of regulatory strategies
- Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning
- Creation of simple, clear, and concise procedures
- Preparation of Clinical Evaluation Reviews for inclusion in product Technical Files

**What’s next? It’s easy Click “APPLY” now We can’t wait to hear from you**

**Salary**: £23,000.00-£27,500.00 per year

Work Location: In person

Reference ID: TNCRL - 007

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