Your Job

P hillips-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

• Design & Development Stage
• Be the contact window to transfer quality documentation from GID centers to multiple Phillips-Medisize manufacturing locations, also be the quality leader to ensure all the quality deliverables from manufacturing locations could meet the requirements during Design & Development stages. Work directly with the Regulatory Affairs Team to ensure alignment and any gaps are addressed.
• NPI & Mass Production Stages
• Lead and coordinate the NPI AQP processes in terms of quality responsible areas by leveraging the quality resources from different quality organization in multiple Phillips-Medisize manufacturing facilities producing for the common strategic customers.
• Drive the customer relationship management process between all Phillips-Medisize facilities and the strategic customer quality organizations, act 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.
• Participate in regular business reviews providing 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, feedbacks and complaints, as well as the reporting to authorities by the assistance from the manufacturing locations and regional RA representatives.
• Coordinate with internal RA (Regulatory Affairs) Teams or external RA consultants coordinating registration and post market regualtory activities are met for various global jurisdictions / markets.

Who You Are (Basic Qualifications)

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

What Will Put You Ahead

• 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, ie. project management.
• Business insights and strategic thinking including ability to handle top pharma company expectations.
• Strong stakeholder management skills
• Embrace 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.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

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