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About the job
My client are a global healthcare company who, due to continued growth, have an exciting opportunity for a Quality Manager to join their team in Reading.
Reporting to the Quality Director we are looking for a Quality Manager / Post Market Surveillance to join our team. The post will ensure product safety & efficacy is adequately maintained in the field in compliance with all relevant global regulations and customer requirements.
You will be the process owner for the Post Market Surveillance (PMS) system and ensure efficient product data analysis using an integrated risk management process driving patient safety and improved product reliability.
Accountable for Post Market Surveillance system
Accountable for product complaint process
Leading assigned teams of Associates
Driving Team & process performance as per Quality and Business objectives
Monitor and report out quality performance for area of responsibilities
Accountable for compliance for area of responsibilities
Requires a minimum of engineering degree in science, with a minimum of 5 years of relevant experience in the medical device industry with a focus on post market vigilance processes such as complaint management, vigilance reporting, risk management and CAPA.
You will have the ability to make timely critical decisions regarding product quality and/or quality system compliance.
An individual in this role must have proven leadership, communication, organization and project management skills. You should have the ability to communicate efficiently to MMS leadership team, internal customers and key stakeholders. Able to effectively lead and influence teams across the matrix toward process changes or problem solving.
We are looking for someone with the ability to evolve a quality system towards higher levels of performance, efficiency, and compliance. A strong knowledge of WW medical device regulations.
A strong working knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, FMEA/Fault Tree Analysis. Capacity to work with information systems such as Trackwise, SAP. Good Technical writing skills.
Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.
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