Clinical Quality Associate/Auditor GCPPermanentLocation: HullHighly Competitive Salary + BenefitsSRG are currently recruiting on behalf of a global Healthcare and FMCG organisation who are seeking an...
Lead Auditor / Continuous Improvement Manager - Cheshire - Medical Devices - Permanent
SRG are working with a highly regarded Medical Device manufacturer who are looking to take on a permanent Lead Auditor / Continuous Improvement Manager. The company in question are all about improving the lives of both their customers and their staff by creating a continually improving product and environment- which is proven by their continual success.
Purpose of Role;
Responsible for verifying and maintaining compliance with ISO 13485 (Medical Devices Standard), and for improving quality systems.
* Provide education, verification and maintenance for the ISO 13485.* Lead and manage the UK ISO 13485 internal audit team and QMS* Review, evaluate, advise and support internal audit team audit and resolution activities.* Knowledge of European regulations, ideally medical devices* Coordinate Regulatory educational/informational meetings with managers and supervisors.* Ensure and verify that all internal and external requirements are being completed on time and in compliance with all applicable regulatory guidelines. * Ensure the quality system is audited on a scheduled basis to verify conformity.* Represent the UK facility as QMS Management Representative in all external audit functions. * Report to Management on all audit results, internal and external.* Advise management on appropriate regulatory conformance, including European regulations.* Coordinate lean manufacturing and lean office improvement activities
Experience:Experience working with ISO 13485 quality systems
Knowledge* Knowledge of European regulatory affairs required.* Familiarity with production functions required.* Knowledge of ISO 13485 criteria and associated standards required.* Knowledge of Lean Principles required
If interested please send an updated CV or call 0161 868 2236 for more information.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.