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Engineering Change Control Lead/Supervisor

Posted on Jun 17, 2019 by CV-Library

Runcorn, Cheshire, United Kingdom
Immediate Start
Annual Salary
Change Control Specialist

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

Reference: 210234640