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Global Quality Account Manager

1 miesiąc temu

Siemianowice Śląskie, Silesia, Polska Phillips-Medisize Pełny etat

Job Summary

Phillips-Medisize is seeking a Quality Account Manager to serve as the key quality contact for strategic customers, ensuring seamless quality documentation transfer between manufacturing locations and GID centers.

Key Responsibilities

  • Design & Development Stage:
    • Collaborate with Regulatory Affairs Team to ensure quality documentation meets requirements.
    • Coordinate quality deliverables from manufacturing locations to meet Design & Development stage needs.
  • NPI & Mass Production Stages:
    • Lead NPI AQP processes, leveraging quality resources from multiple manufacturing facilities.
    • Drive customer relationship management, acting as principal quality liaison between Phillips-Medisize facilities and strategic customer quality organizations.
    • Negotiate, review, and approve quality agreements and requirements from strategic customers.
    • Participate in regular business reviews, providing quality updates on behalf of all Phillips-Medisize facilities producing for strategic customers.
    • Track and report quality improvement initiatives and action items for strategic customers.
    • Participate in post-market changes, feedbacks, and complaints, as well as reporting to authorities with assistance from manufacturing locations and regional RA representatives.

Requirements

  • Bachelor's degree in engineering.
  • Several years of experience in Project/Quality engineering.
  • Familiarity with ISO13485, QSR 820, NMPA regulations, etc.

Preferred Qualifications

  • 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.
  • 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 with contingency plans.
  • Ability to travel to Customers or Manufacturing Sites at least 10% of the time.

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