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
2. Serve as the primary contact to transfer quality documentation from GID centers to multiple Phillips-Medisize manufacturing locations. Lead quality efforts to ensure all deliverables meet requirements during Design & Development stages. Collaborate with the Regulatory Affairs Team to address any gaps.
3. NPI & Mass Production Stages
4. Lead and coordinate the NPI AQP processes, leveraging quality resources across multiple facilities producing for strategic customers.
5. Manage customer relationships between Phillips-Medisize facilities and customer quality organizations, acting as the principal quality liaison.
6. Negotiate, review, and approve quality agreements and requirements from strategic customers.
7. Participate in business reviews, providing quality updates.
8. Track and report quality improvement initiatives and actions.
9. Participate in post-market activities, feedback, complaints, and reporting to authorities.
10. Coordinate with Regulatory Affairs teams for registration and post-market regulatory activities globally.
Who You Are (Basic Qualifications)
* Several years of experience in Project/Quality engineering.
* Familiarity with ISO13485, QSR 820, NMPA regulations, etc.
What Will Put You Ahead
* Regulatory Affairs background.
* Technical skills in injection molding tooling, materials, manufacturing, quality, and product design.
* Leadership skills, including confidentiality, project management, and driving new processes.
* Business insights and strategic thinking, capable of handling top pharma company expectations.
* Embrace diversity in culture and personality.
* Excellent communication, teamwork, and organizational skills.
* Ability to develop and meet project schedules with contingency plans.
* Willingness to travel at least 10% of the time to customers or manufacturing sites.
#J-18808-Ljbffr