Description
A Medical Device client based in the North West are looking to bring on a Quality Assurance (QA) Auditor on a contract basis. It will be an initial 6 months contract with the view to extend if you impress.The purpose of this role is to manage quality system audit activities to ensure continual improvement of processes and conformity to regulatory requirements.
The role specific responsibilities include:
*Maintain and manage the quality audit processes, identify and implement system improvements.
*Generate and execute the internal audit plan, review plan on a monthly basis.
*Compile audit reports, agree deficiencies, actions and timelines with Auditee.
*Monitor all audit actions and review objective evidence to approve for closure as required.
*Ensure the company is informed and has up-to-date information on all applicable quality system specifications and standards e.g. ISO, CFR.
*Act as guide for regulatory body audits.
*Produce weekly, monthly, quarterly and annual metrics relating to responsibilities, trend and propose corrective actions.
*Form and co-ordinate cross functional implementation teams when appropriate.
*Review and update quality assurance working practices and associated documentation to ensure conformity to regulatory requirements.
The key skills and experience required:
*Certified Lead Auditor in ISO9001 with substantial proven experience within a regulated occupational environment.
*Proven experience of facilitating regulatory body assessment and certification audits e.g. LRQA, FDA
*Desirable = certified auditor or proven experience in ISO 9001 TickIT
*Proven knowledge of ISO 9001, ISO 13485, 21 CFR part 820
*Good written and oral communication skills are required for example [to ensure succinct report generation, effective communication with staff, peer groups etc across organisation.
*Must be able to work independently and communicate with all levels of the organisation
*Computer literate, preferably with knowledge of software packages such as Word, Excel to for example [produce letters, management reports, analyse data etc]
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.
Thanks and regards,
Nathan Puxty