Engineering Change Control Lead/Supervisor

Recruiter
SRG
Location
Runcorn, UK
Salary
Competitive
Posted
18 Jun 2019
Closes
26 Jun 2019
Ref
1184062664
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
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

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