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Global Quality Account Manager - Medical Industry, Siemianowice Slaskie

Client:

Phillips-Medisize

Location:

Siemianowice Slaskie

Job Category:

Other

EU work permit required:

Yes

Job Reference:

671e0d6a75ab

Job Views:

19

Posted:

23.01.2025

Expiry Date:

09.03.2025

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
   • 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
   • 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 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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