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Global Quality Account Manager - Suzhou, 中国 - Phillips-Medisize
描述
Position: Quality Account Manager
Phillips-Medisize is seeking a Quality Account Manager to be the key quality contact for strategic customers involving multiple Phillips-Medisize manufacturing locations and development centers, mainly supporting our platform business from Design and Development through Commercialization.
Essential Functions:
Design & Development Stage
·Coordinator the transfer of quality requirements from customer to development team.
·Coordinate the transfer quality requirements and documentation from Development centers to multiple Phillips-Medisize manufacturing locations and ensure all the quality deliverables from manufacturing locations meet the requirements during Design & Development stages.
·Coordinate with the Regulatory Affairs (RA) team to facilitate alignment and any gaps are addressed.
New Product Introductions (NPI) & Commercial Production Stages
·Coordinate the NPI processes for quality areas by using resources from different quality organization in multiple Phillips-Medisize manufacturing facilities producing for shared strategic customers.
·Drive the customer relationship management process between all Phillips-Medisize facilities and the strategic customer quality organizations, function 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 in collaboration with the appropriate Phillips-Medisize manufacturing facilities.
·Participate in regular business reviews supplying 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, feedback and complaints, as well as the reporting to authorities by the from the manufacturing locations and regional RA representatives.
·Coordinate with internal Regulatory Affairs teams or external RA consultants coordinating registration and post market regulatory activities are met for various global jurisdictions / markets.
Required Qualifications:
·B.S. or Master degree in engineering or technical field with a minimum of 5 years of related experience.
·Technical injection molding tooling, materials, manufacturing, quality, and product design skills.
·ISO13485, QSR 820, MDR etc.
Skills and Abilities:
·Leadership skills including ability to maintain confidentiality and drive projects and new business processes, i.e., project management.
·Business insights and strategic thinking including ability to manage 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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