Quality Lead Manufacturing Medical devices

3 weeks 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



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