Description
A medical device company are looking for a Quality/Regulatory (QA/RA) Manager on a contract basis whilst they finding the permanent solution. The contract is likely to run on for 4-6 months and it is office based in Oxfordshire.The purpose of this role is to maintain, implement and review Quality Management and Environmental processes within the company to ensure regulatory compliance of all company processes and products.
Main responsibilities include:
*Maintain and implement Quality Management systems to comply with ISO13485 and ISO9001 across the Toumaz Group.
*Maintain and implement Environmental Management system to comply with ISO14001 across the sites that have implemented it.
*Responsible for ensuring regulatory compliance to Medical Device Directive 93/42/EC and all other relevant medical product directives.
*Work with internal product development teams and external subcontractors to ensure regulatory compliance of products.
*Plan and perform regular internal audits to ensure processes, project documentation and Technical Files comply with relevant regulatory requirements.
*Appointed Management Representative for liaising with Notified and Competent Bodies regarding changes in QMS, submission of clinical trial applications and reporting Adverse Incidents.
*Co-ordinate post market surveillance investigations caused by product yield or customer complaint.
*Implementation, in association with company directors, of any product recall or issuing of Advisory Notices to customers.
Skills/experience required:
*Experience in communication with Competent Bodies for medical products
*Training in Medical Device regulatory issues and Quality Management Systems.
*An engineering degree and a minimum of 10 years experience in a Quality management/engineering role.
*Substantial experience of implementing and driving quality improvement programmes within technology development organisations
*Understanding and experience of silicon, PCBA, and embedded software quality requirements and issues.
*Knowledge of Silicon/SMT assembly processes and 8D methodology.
*Product Reliability/Qualification programs.
Please get back in touch on receipt of this email if this is of interest.
If you know of anyone who may be interested we offer vouchers up to £200 for a referral that results in a placement.
Kind regards,
Nathan Puxty