Are you an experienced quality administrator or engineer? Do you have experience in managing multiple records from a document control and data entry point of view?

We are recruiting for an Associate Quality Engineer to be accountable for supporting QA Engineers', Lead QA Engineers' and QA Managers' activities. This includes supporting the development and maintenance of their Quality System procedures for Design Control, Process Validation, Software Validation and Manufacturing QA.

The successful candidate will be joining our clients Witney site, working 37.5 hours a week Monday to Friday. This position is offered as a contract opportunity for 6 months initially, with the potential to be extended or turn into a permanent position.

Responsibilities:

• Collating and reporting metrics for review.
• Reporting on and supporting the implementation of actions to reduce the occurrence/reoccurrence of non-conformances within Manufacturing, Product Test, Incoming Materials, Clinicals and Development.
• Maintaining Design History Files (DHFs) and Validation documents as required.
• Supporting Validation activities by maintaining the Site Validation Master Plan and associated listings.
• Recording and issuing minutes for technical meetings such as Validation Review Board (VRB) and tracking actions to completion as appropriate.
• Monitor and maintain the quality and compliance status of associated quality records:
• Ensure submitted Quality Records are in compliance with Quality System and planned requirements.
• Review, provide feedback and complete final approval of Quality Records.
• Monitor and maintain risk management reports / records such as process Failure Modes and Effects Analysis (pFMEA) and software risk analyses.
• Maintain site validation plans, listings and periodic review process
• Provide validation input to post market surveillance activities.
• Present and communicate status, report metrics, identify trends potential issues, improvement initiatives and Corrective and Preventive Action (CAPA) requirements.
• Device Master Record change control.
• Product performance monitoring of PT release data.
• Monitor and maintain Risk management plans and associated records eg design risk analysis and design FMEA.
• Provide design input to post market surveillance activities.
• Present and communicate status, report metrics, identify trends potential issues, improvement initiatives and CAPA requirements.
• DHF creation and maintenance.
• Change control of product and material requirements.
• Product performance monitoring of stability and clinical data.
• Maintain the quality and compliance status of associated Procedures, work instructions and training materials:
• Identify and implement initiatives for continuous improvement of the Quality System.

Experience & Qualifications:

• Educated to Secondary Level including GSCE Science, English and Mathematics, as the jobholder will need to support Technical teams and understand documents of a scientific and technical nature
• Prior experience of working with software packages such as Word and Excel in order to manage data, collate metrics, produce reports and minutes.
• Prior experience of working within and supporting a team.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.