Description
Vivid Resourcing are recruiting for a 6 month contract position for a Medical Devices Company looking for a Quality Engineer.
The ideal candidate will have experience within Medical Devices Directive, In Vitro Diagnostics Directive, ISO 9001, ISO 13485 and ISO 14971, and 21 CFR part 820.
Key Responsibilities include:
- Ensure that all customer complaints are logged in the relevant company systems in a timely manner in-line with company procedures
- Ensure that customer reported complaints are investigated adequately and that root cause findings and corrective action results are communicated to appropriate internal stakeholders in a timely manner
- Prepare reports for MDV and MDR in EU and US and provide support for any communications with relevant regulators as required
- Assist with the investigation, risk assessment and resolution of product quality issues
- Maintain the product Technical Files, including updating risk the Risk Management File, Essential Requirements Checklist and Clinical Evaluation following product quality issue investigations or design, process or regulatory changes
- Provide support for updates to Instructions for Use and Labels as required following product quality issue investigations or design, process or regulatory changes
- Authorship of the Post Market Clinical Follow Up Plan and coordination of the work to implement this
- Support maintenance of existing products following design, process or supplier changes
- Coordinate the validation of the effectiveness of proposed post market solutions and their implementation in the field with other departments as required and update the Technical File as appropriate
- Ensure that internal post-market processes continue to be effective and meet regulatory requirements
- Report on KPI relating to post market activities and customer complaints
- Be part of the Internal Audit team and support audits of Suppliers
- Assist with external audits to achieve and maintain ISO accreditation
- Support the QMS as required by the QA Manager
- Provide leadership in the understanding of medical device regulations to other disciplines
- Provide a positive example and actively promote compliance to all standards
If this sounds like this is for you then please apply below or refer a friend.
Thank you
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.