Quality and Regulatory Systems Engineer

Quality and Regulatory Systems Engineer – Homebased

Opportunity:

Are you currently working as a quality and regulatory engineer looking for your next role? Have you implemented or maintained a quality management system? Do you have experience in dealing with NCR/CAPA’s and change controls? Looking for your next contract role based working from home with an exciting global medical device company? If yes then this is the role for you.

Your role as a Quality and Regulatory Systems Engineer based working from home will involve supporting the QA/RA department and working with all other departments to secure and maintain quality & regulatory compliance across the medical device product range.

Duties and responsibilities include:

* NCR/CAPA – Root cause analysis, monitoring of open NCR/CAPA’s.

* Change control – Monitoring of open change control, raising new change control.

* EQMS – Performing document control activities, including creating, distributing, modifying, storing and reviewing documents and records.

* Post-Market Surveillance activities: Assisting with PMCF plans, PMS data collection, analysis and reporting.

* Supporting the registration of new products for UK, EU & ROW.

* Managing product vigilance issues, including field safety notices, customer advisory notices and liaison with National Competent Authorities as required.

* Risk Management of medical devices.

* Software validation – Writing test cases/executing test cases.

* Supplier quality assurance development.

This is a full time permanent job opportunity paying an excellent salary of £40,000 - £45,000 per annum plus great benefits. The role is based working from home and to attend the site in Walsall, West Midlands approx 2-3 times every fortnight and as and when required.

Skills:

To apply for the role of Quality Systems Engineer you will have the following:

* Ideally quality systems engineering experience within medical device industry.

* Notified body audit experience.

* Experience of QMS implementation.

* Excel – Advanced.

How to Apply:

To apply for this one off opportunity, please send a word copy of your CV to me now by clicking on the Apply button or call me for a confidential chat. Please ensure you have read and agree to our Privacy Policy which can be found on the Quality Start website.

If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes for referring contractors/temp staff so please contact us with the referral and we can provide you with more information.

For a list of our current vacancies, please visit the Quality Start website.

If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.

Quality Start are acting as a specialist recruitment consultancy for this role