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Quality Lead Manufacturing Medical devices

2 months ago

United Kingdom Athsai Full time

Designation

Quality Lead

North West England


Duration of the Project*

6months to 1 year (Tentative, may extend)


Domain

Mechanical/Bio Medical


Collaborates with strategic network project team to deliver in-load of product families to the site


Partners with NPD, Manufacturing Engineering and other cross functional partners to ensure the proper application of design controls, risk management and process and test method validation activities in line with franchise and site procedures.


Supports the development of quality strategies related to the transfer of products, materials and components within


Provides supervision, mentoring, coaching, and performance review, for project quality engineers.


Approve IQ, OQ, PQ, TMV or Software Validation



Risk Mitigation



Conduct strategic planning with Project leaders and Manufacturing Engineering Team. Partners with other functions to establish business priorities and resource allocation



Ensures effective quality strategies are created for the validation of test methods and processes.



For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable




Mandatory Skills*


Quality Management strategy define and implementation

Good


Collaboration, Mentoring, Coaching, accountable for all levels of quality function

Good


CAPA/PFMEA/Control Plan/Lean Six Sigma methodology

Good


Manufacturing Processes relevant to medical devices

Good



upma@athsai.co.uk