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Client:
Phillips-Medisize
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Job Category:
Other
EU work permit required:
Yes
Job Reference:
db4affcbcb28
Job Views:
1
Posted:
29.03.2025
Expiry Date:
13.05.2025
Job Description:
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
1. Design & Development Stage
o 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.
2. NPI & Mass Production Stages
o 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.
o 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.
o Negotiate, review and approve the quality agreements and other quality requirements from strategic customers.
o Participate in regular business reviews providing quality updates on the behalf of all Phillips-Medisize facilities producing for the strategic customers.
o Track and report quality improvement initiatives and action items for the strategic customers.
o 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.
o Coordinate with internal RA (Regulatory Affairs) Teams or external RA consultants coordinating registration and post market regulatory activities are met for various global jurisdictions / markets.
Who You Are (Basic Qualifications)
* 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.
* 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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