Quality Assistant

4 weeks ago

Worcestershire, United Kingdom Bausch + Lomb Full time

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 90 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.

**General responsibilities to include**:

- 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, deviations and CAPA management processes.
- Update Q Pulse with Product Drawings from Technical Department for approval.
- Creation of Certificates of analysis for the Sales and Quality departments.
- Administration and updating of technical file documentation (DOC, DMR, Biological Evaluations, Post Market Surveillance etc).
- Creation / Modification / Update of internal SOPs and documents 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 periodic environmental monitoring 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 the Quality department and general office duties as required
- Administration of the nomenclature systems for labelling and registration.
- Providing data and support for the updating of department QPIs.
- Helping with administering implementation of UKCA, MDR and MDSAP requirements.
- Administering Contract Approval Form process.
- Administration of change control process.
- Creation of testing protocols to standards and test processes.
- Undertake continuous training and development.
- Other tasks as required to support the needs of the Quality department.

**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

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