Global Quality Account Manager

3 weeks ago

Sligo, Ireland Phillips-Medisize Full time

Your Job

Phillips-Medisize is seeking a Quality Account Manager to be the key quality contact for strategic customers involving multiple Phillips-Medisize manufacturing locations and GID centers, mainly supporting our platform business from Design and Development through Commercialization.

What You Will Do

Design & Development Stage  Be the contact window to transfer quality documentation from GID centers to multiple Phillips-Medisize manufacturing locations, also be the quality leader to ensure all the quality deliverables from manufacturing locations could meet the requirements during Design & Development stages. Work directly with the Regulatory Affairs Team to ensure alignment and any gaps are addressed. NPI & Mass Production Stages Lead and coordinate the NPI AQP processes in terms of quality responsible areas by leveraging the quality resources from different quality organization in multiple Phillips-Medisize manufacturing facilities producing for the common strategic customers. Drive the customer relationship management process between all Phillips-Medisize facilities and the strategic customer quality organizations, act as principal quality liaison between Phillips-Medisize facilities and the strategic customer, responding appropriately to internal and external customer needs. Negotiate, review and approve the quality agreements and other quality requirements from strategic customers. Participate in regular business reviews providing quality updates on the behalf of all Phillips-Medisize facilities producing for the strategic customers. Track and report quality improvement initiatives and action items for the strategic customers. Participate in post market changes, feedbacks and complaints, as well as the reporting to authorities by the assistance from the manufacturing locations and regional RA representatives. Coordinate with internal RA (Regulatory Affairs) Teams or external RA consultants coordinating registration and post market regualtory activities are met for various global jurisdictions / markets. 

Who You Are (Basic Qualifications)

Bachelor’s degree in engineering. Several years of experience in Project/Quality engineering. Be familiar with ISO13485, QSR 820, NMPA regulations etc.

What Will Put You Ahead

RA (Regulatory Affairs) background Technical injection molding tooling, materials, manufacturing, quality, and product design skills. Leadership skills including ability to maintain confidentiality and drive projects and new business processes, ie. project management. Business insights and strategic thinking including ability to handle top pharma company expectations. Strong stakeholder management skills Embrace diversity (culture and personality). Demonstrated superior communication, teamwork, and organizational skills. Ability to develop and meet project/program schedules, along with contingency plans. Ability to travel to Customers or Manufacturing Sites at least 10% of the time.

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