Global Quality Account Manager
2 dni temu
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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