QA/RA Assistant required to work for a rapid growing business based in the Wokingham area. Permanent opportunity - Immediate start
The successful candidate will be responsible for the maintenance and update of Design & Technical Documentation Files to demonstrate conformity to essential requirements and essential principles of safety and performance, to ensure compliance to European and Global regulatory requirements.
- To compile and maintain EU Technical Documentation Files as per EU IVDD Directive.
- To contribute towards transitioning from IVDD to IVDR.
- To assist Head of R&D in writing, collating and maintenance of Design Files as per the procedure and in line with ISO 13485.
- To assist technical and regulatory departments in writing, collating and maintenance of the Technical Files.
- To follow and review procedures and work instructions in line with any regulatory requirements, audits and standard practice.
- To check documentation for correctness and regulatory compliance and to assist with technical documentation regulatory compliance enquiries.
- Assistance in quality and regulatory projects, processes and activities.
- To attend team meetings to discuss any arising issues and take the minutes of meetings as required.
- To assist in review meetings to plan closure of all audit findings.
- To peer review Design/Technical Files as compiled by other team members.
- To record any projects or notifications which bear impact on Design/Technical files to ensure relevant updates to all packages.
- To keep relevant records in the Tracker and Progress reports to show progress.
- To attend technical file reviews, technical standards and other meetings as appropriate.
- To provide administrative support to the QA/RA department.
- Management and collation of all the necessary regulatory documentation required for product registration submissions.
- To carry out any other reasonable tasks as required by the company.
- Monitor every stage of production to avoid product defects.
- Carryout Incoming Quality Control Checks.
- Ensure there is quality testing all the time; carry out inspections so as to meet the standard set by the organization.
- Reviewing of the calibration labels and reports in the production area.
- Ensure current forms are used and completed.
- Ensure good documentation practices are followed.
- Ensure all the QC Work Instructions are up to date and correct.
- Review and filing of the batch records as required.
Company and Benefits: Company based in Wokingham, parking on site
21 days holiday + 1 day every year + ½ day on birthdays
1 day work from home-semi flexi
If you have the relevant experience and are interested in a new opportunity, APPLY NOW!!
Permanent, Full Time
- Industry Sector Manufacturing