Global Quality Account Manager - Medical Industry

Your Job

P hillips-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 ...