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Global Quality Account Manager
2 months ago
About the Role
Phillips-Medisize is seeking a Quality Account Manager to serve as the key quality contact for strategic customers involving multiple Phillips-Medisize manufacturing locations and GID centers. This role will primarily support our platform business from Design and Development through Commercialization.
Key Responsibilities
- Design & Development Stage
- Act as the primary point of contact to transfer quality documentation from GID centers to multiple Phillips-Medisize manufacturing locations, ensuring all quality deliverables meet requirements during Design & Development stages. Collaborate with the Regulatory Affairs Team to ensure alignment and address any gaps.
- NPI & Mass Production Stages
- Lead and coordinate NPI AQP processes, leveraging quality resources from various Phillips-Medisize manufacturing facilities producing for strategic customers.
- Drive customer relationship management between Phillips-Medisize facilities and strategic customer quality organizations, serving as the principal quality liaison between Phillips-Medisize facilities and strategic customers.
- Negotiate, review, and approve quality agreements and other quality 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.
- Coordinate with internal RA Teams or external RA consultants to ensure registration and post-market regulatory activities meet global jurisdiction/market requirements.
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.
- Embracing 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.
