Global Quality Account Manager
Position: Quality Account Manager
Phillips-Medisize is seeking a Quality Account Manager to be the key quality contact for strategic customers involving multiple Phillips-Medisize manufacturing locations and development centers, mainly supporting our platform business from Design and Development through Commercialization.
Essential Functions:
Design & Development Stage
• Coordinator the transfer of quality requirements from customer to development team.
• Coordinate the transfer quality requirements and documentation from Development centers to multiple Phillips-Medisize manufacturing locations and ensure all the quality deliverables from manufacturing locations meet the requirements during Design & Development stages.
• Coordinate with the Regulatory Affairs (RA) team to facilitate alignment and any gaps are addressed.
New Product Introductions (NPI) & Commercial Production Stages
• Coordinate the NPI processes for quality areas by using resources from different quality organization in multiple Phillips-Medisize manufacturing facilities producing for shared strategic customers.
• Drive the customer relationship management process between all Phillips-Medisize facilities and the strategic customer quality organizations, function as principal quality liaison between Phillips-Medisize facilities and the strategic customer, responding appropriately to internal and external customer needs.
• Negotiate, review and approve the quality agreements and other quality requirements from strategic customers in collaboration with the appropriate Phillips-Medisize manufacturing facilities.
• Participate in regular business reviews supplying quality updates on the behalf of all Phillips-Medisize facilities producing for the strategic customers.
• Track and report quality improvement initiatives and action items for the strategic customers.
• Participate in post market changes, feedback and complaints, as well as the reporting to authorities by the assistance from the manufacturing locations and regional RA representatives.
• Coordinate with internal Regulatory Affairs teams or external RA consultants coordinating registration and post market regulatory activities are met for various global jurisdictions / markets.
Required Qualifications:
• B.S.
or Master degree in engineering or technical field with a minimum of 5 years of related experience.
• Quality engineering experience, including customer engagement, advanced quality planning, validation or sustaining quality management, minimum 3 years.
• Technical injection molding tooling, materials, manufacturing, quality, and product design skills.
• ISO13485, QSR 820, MDR etc.
• Regulatory Affairs background, India and China market is preferred.
Skills and Abilities:
• Leadership skills including ability to maintain confidentiality and drive projects and new business processes, i.e., project management.
• Business insights and strategic thinking including a...
- Rate: Not Specified
- Location: Suzhou, CN-32
- Type: Permanent
- Industry: IT
- Recruiter: Phillips-Medisize
- Contact: Not Specified
- Email: to view click here
- Reference: 153301-en_US-CN-SUZHOU-006
- Posted: 2024-05-07 08:45:34 -
- View all Jobs from Phillips-Medisize
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