Connecting Talent to opportunity

Connecting Talent to opportunity

QA RA Assistant

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Job Description:

QA/RA Assistant required to work for a rapid growing business based in the Wokingham area. Permanent opportunity - Immediate start 

 

Role: 

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.

RESPONSIBILITIES:                 

  • 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

Standard pension

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!! 

 

  • Job Type

    Permanent, Full Time

  • Work Authorisation

    No

  • Industry Sector Manufacturing

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