Engineering Change Control Lead/Supervisor
Posted on Jun 17, 2019 by CV-Library
Are you a Quality Assurance professional with a background in the Medical Device or Pharmaceutical industry? Do you have experience in product verification and design?
My client, a prestigious name in Medical Devices, are currently recruiting for a Change Control Specialist to be based at their Runcorn site.
Your role will be to:
* Own the end to end process for engineering change, verification and validation
* Develop and implement robust verification and validation processes
* Ensure consistency of approach, utilising risk, evidence and results based protocols, trials and reports.
* Provide technical authoring expertise and training to the team
* Chair, or assign a team member to chair the change control meetings
* Maintain efficacy of the Device Master Records and revision control
* Control the approval and release of concessions, rework instructions, deviations.
* Work cross-functionally to ensure actions are deadlines are complete. Assist with the identification and implementation of regulatory requirements, thus sustaining compliant, saleable products:
* Regulations, including IEC61010, REACH, RoHS, UDI
* Part obsolescence, Last time buy
* UL and EMC testing
* Directly manage small team of 2 – Change Control Administrator and Verification & Validation Technician. Take an active hand in the training and development of the latter.
The ideal candidate will have:
* Strong background in engineering change or compliance
* Degree or HND in an Engineering or Science based subject
* Experience of a team lead role within a multi-disciplined engineering team, or the ability to demonstrate the requisite leadership competencies to step up into team leadership
* Capable of fully understanding and implementing the regulatory standards relating to Medical Devices and IVD
* Proven ability to make quick decisions and act decisively
* Able to gain a solid understanding of systems: Dataflo (ERP) and Q-Pulse (QMS)
* Attention to detail & drives a right first time” approach
* Proven ability to build strong cross-functional relationships and influence others
* Ability to lead effective meetings and drive to closure on action items
* Outstanding written, verbal, presentation, and influencing skills
* Ability to use Continuous improvement techniques, such as value stream maps & Kaizens to effect change
* Experience of using DOE, Engineering studies and V&V as part of a robust change control process
If you are interested in this role or would like more information please apply now or send an email