Collaborates with strategic network project team to deliver in-load of product families to the Blackpool 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 J&J.
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 Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks 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 Documentation and Reporting Good MS office Good Desired Skills Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks
1. Strong interpersonal and excellent communication skills with good team spirit.
Expertise
2. Problem solving abilities, data analysis and interpretation
Good
3. Experience in Medical Devices Manufacturing - Preferred
Good