Global Quality Account Manager

2 dni 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 and alignment across multiple manufacturing locations and GID centers.

Key Responsibilities

  • Develop and maintain quality documentation, ensuring compliance with ISO13485, QSR 820, and NMPA regulations.
  • Collaborate with the Regulatory Affairs Team to ensure alignment and address any gaps in quality deliverables.
  • Lead and coordinate NPI AQP processes, leveraging quality resources from multiple manufacturing facilities.
  • Negotiate and review quality agreements with strategic customers, ensuring alignment with company policies.
  • Participate in regular business reviews, providing quality updates and tracking improvement initiatives.
  • Coordinate post-market changes, feedbacks, and complaints, ensuring compliance with regulatory requirements.

Requirements

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

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.
  • Business insights and strategic thinking, including ability to handle top pharma company expectations.
  • Strong stakeholder management skills.
  • Ability to travel to customers or manufacturing sites at least 10% of the time.

What We Offer

Phillips-Medisize offers a dynamic work environment, opportunities for professional growth, and a competitive compensation package.



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