Quality Compliance Specialist

Sterimedix Ltd

Sep 6th, 2022
£ 26,000 - 28,000 / Year

Sterimedix is a world leader in the production of medical devices for use in eye and aesthetic surgery. Based in Redditch, which has a rich history in needle making, the company employs over 70 people in Production, Sales, Quality, Despatch, Finance and Administration. The Company has ambitious plans for growth based on a track record of increased sales each year. It recently moved into a new and much larger facility in North Moons Moat. The team at Sterimedix sells its products all over the world. It is a dynamic and interesting company where individuals can actively contribute to and share in its success.

We wish to appoint a Quality Compliance Specialist who will report to the Medical Regulatory Compliance Specialist

Key Responsibilities:

  • Completion of customer quality and regulatory questionnaires in line with company procedure.
  • Control the new product introduction forms and track their status and report to the management team on a weekly basis.
  • Administration of the internal audit system
  • Update Q Pulse with supplier details, quality questionnaires and audit schedules driven by the new supplier process.
  • Update Q Pulse with Product Drawings from Technical Department for approval.
  • Creation of Certificates of analysis for the Sales and Regulatory departments
  • Administration and updating of technical file documentation (DOC, DMR, Biological Evaluations, Post Market Surveillance etc)
  • Creation / Modification / Update of internal SOPs and submission for approval on Q Pulse
  • Collating customer feedback and assisting with the analysis and submission into the PMS system.
  • Responding to customer specific requirements for Registrations
  • Tracking updates to Standards and updating management, GAP Analysis.
  • Administering Bioburden results and reporting trends
  • Assisting with the registration of company products in markets as per management request.
  • Administering customer communications for regulatory updates.
  • General administration for regulatory and quality department and general office duties including filing, archiving.
  • Raise any non-conformances by filling out the correct documents and passing on to the Regulatory and Quality Manager.
  • Administration of the nomenclature systems for labelling and registration.
  • Providing data and support for the updating of department KPIs
  • Helping with administering implementation of UKCA, MDR and MDSAP requirements.
  • Administering Contract Approval Form process.
  • Administration of significant change process.
  • Creation of testing protocols to standards and test processes.
  • Undertake continuous training and development
  • Other tasks as and when required.

Required Experience:

· Experience in Manufacturing (Preferred)

· Experience in Medical Device Industry (Preferred)

· Computer skills

Salary & Benefits:

· 25 days annual leave + bank holidays

· Company Sick Pay

· Health Cash Plan Scheme

· Group Life Assurance Scheme

· Contributory Pension Scheme, Employer contribution 5%

· Free On-site Parking

· Early finish Fridays

Hours:

· 37.5 hours per week Mon-Fri

Job Types:
· Full-time, Permanent

Job Types: Full-time, Permanent

Salary: £26,000.00-£28,000.00 per year

Benefits:

  • Company events
  • Free parking
  • Life insurance
  • On-site parking
  • Sick pay
  • Wellness programme

Schedule:

  • Monday to Friday

Ability to commute/relocate:

  • Redditch, B98 9ND: reliably commute or plan to relocate before starting work (required)

Experience:

  • Quality assurance: 1 year (required)

If you require alternative methods of application or screening, you must approach Sterimedix Ltd directly to request this, as we're not responsible for the employer's application process.

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