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
- 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.
· 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
· 37.5 hours per week Mon-Fri
· Full-time, Permanent
Job Types: Full-time, Permanent
Salary: £26,000.00-£28,000.00 per year
- Company events
- Free parking
- Life insurance
- On-site parking
- Sick pay
- Wellness programme
- Monday to Friday
Ability to commute/relocate:
- Redditch, B98 9ND: reliably commute or plan to relocate before starting work (required)
- Quality assurance: 1 year (required)