Global Quality Account Manager

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 assistance 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.

• Quality engineering experience, including customer engagement, advanced quality planning, validation or sustaining quality management, minimum 3 years.

• Technical injection molding tooling, materials, manufacturing, quality, and product design skills.

• ISO13485, QSR 820, MDR etc.

• Regulatory Affairs background, India and China market is preferred.

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 a...