Quality Lead
7 days ago
As a Quality Lead, you will collaborate with the strategic network project team to deliver in-load of product families to the Blackpool site. You will partner 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.
Main Responsibilities
• Collaborate with the strategic network project team to deliver in-load of product families to the Blackpool site.
• Partner 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.
• Support the development of quality strategies related to the transfer of products, materials, and components within J&J.
• Provide supervision, mentoring, coaching, and performance review for project quality engineers.
• Approve IQ, OQ, PQ, TMV, or Software Validation.
• Conduct strategic planning with Project leaders and Manufacturing Engineering Team.
• Ensure effective quality strategies are created for the validation of test methods and processes.
Requirements
• Good collaboration, mentoring, coaching, and accountability for all levels of quality function.
• Good CAPA/PFMEA/Control Plan/Lean Six Sigma methodology.
• Good manufacturing processes relevant to medical devices.
• Good documentation and reporting.
• Good MS office skills.
Desired Skills
• Strong interpersonal and excellent communication skills with good team spirit.
• Problem-solving abilities, data analysis, and interpretation.
• Experience in Medical Devices Manufacturing - Preferred.
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