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Insulet Corporation
Senior Manager, Supplier Quality APACInsulet Corporation • Gelang Patah, Johor
Senior Manager, Supplier Quality APAC

Senior Manager, Supplier Quality APAC

Insulet Corporation • Gelang Patah, Johor
30+ hari lalu
Penerangan pekerjaan

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our team and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

We are seeking a dynamic and experiencedSenior Manager of Supplier Qualityto support Insulet’s supplier quality assurance program, specifically for the APAC region. This role will focus on developing a high-performing team, strengthening supplier relationships, and ensuring compliance with global regulatory standards. The ideal candidate will bring strong leadership skills, mentoring capabilities, and a passion for supplier quality excellence. Additionally, this role is central to ensuring the growth and development of the Insulet supply base to meet business demands, supporting primarily Insulet’s APAC factories and suppliers.

The Senior Manager of Supplier Quality, APAC needs to thrive in a fast-paced hypergrowth environment, communicate clearly, early and frequently, demonstrate the ability to execute in a deadline-driven environment, and be able to influence change beyond requirements. We are passionate about our customers and products, people, communities, and our planet. We embrace and celebrate diversity and differences including diverse experiences and backgrounds that you may bring to the position. We strive to work with people who are intellectually curious, forward thinking and ready to make an impact. The position reports to the Director, Global Supplier Quality.

Duties and Responsibilities:

Supplier Quality Management & Leadership:

  • Develop and implement supplier quality strategies, ensuring suppliers meet ISO 13485, FDA 21 CFR Part 820, EU MDR, and other regulatory requirements.

  • Lead, mentor, and develop the APAC Supplier Quality team, fostering a culture of accountability, collaboration, and continuous improvement.

  • Provide strategic direction and technical guidance to team members, ensuring alignment with Global Supplier Quality and company objectives.

  • Ensure supplier quality engineers and auditors receive training on industry best practices, risk management, and regulatory compliance.

Team Development & Training:

  • In full alignment with the larger Global Supplier Quality organization, build and manage a high-performing APAC Supplier Quality Team, driving engagement and skill development.

  • Establish individual development plans, leadership coaching, and performance management strategies.

  • Foster a culture of continuous learning, ensuring team members stay updated on emerging regulatory changes, new technologies, and innovative supplier management techniques.

  • Encourage cross-functional collaboration between Quality, Regulatory Affairs, Supplier Development Engineering, Procurement, and Operations to strengthen supplier partnerships.

Supplier Audits, Compliance & Continuous Improvement:

  • Lead supplier audits and performance assessments, ensuring compliance with ISO 13485, FDA regulations, EU MDR, and other global standards.

  • Develop and oversee supplier corrective action plans (SCAR), Failure Mode and Effects Analysis (FMEA), and continuous improvement initiatives.

  • Collaborate with suppliers on process validations, risk mitigation strategies, and defect reduction projects.

  • Maintain clear performance metrics and reporting, ensuring leadership has visibility into supplier quality trends.

  • Lead and collaborate with Global Teams on internal improvement projects related to Supplier Quality processes, and ERP / PLM software integration

Strategic Leadership & Cross-Functional Collaboration:

  • Partner with Regulatory Affairs, R&D, Procurement, Supplier Development Engineering, and Operations to align supplier quality goals with business objectives.

  • Drive strategic supplier development programs, ensuring long-term partnerships that support innovation and operational excellence.

  • Represent the company in industry forums, supplier summits, and regulatory discussions, advocating for best-in-class supplier quality practices.

  • Perform other duties as assigned.

Required Skills and Competencies:

  • Strong technical aptitude which can be applied to an understanding of Insulet’s processes and products

  • Possess basic understanding and experience working with injection molding, PCBA assembly, spring / metal stamping, EtO sterilization and 3rd party device manufacturing.

  • Strategic mindset to ensure adequate level of support in a rapidly changing internal and external environment

  • Collaborate and drive improvement cross-functionally and globally.

  • Implement best practices for compliance processes and procedures.

Education & Experience:

  • Bachelor of Science in Mechanical, Electrical, Materials or Chemical Engineering, Material Science or equivalent

  • 7+ years of experience in Medical Device Quality Operations with 4 or more years at the Quality Manager level. Ideal experience would be in high-volume electromechanical devices.

  • Broad extensive knowledge of methods, processes, equipment, and techniques in Supplier Quality area, particularly those which meet the requirements of ISO 13485, 21 CFR 820, and MDR.

  • Strong leadership and management skills, with the ability to motivate and develop a team.

  • Excellent communication, interpersonal, and presentation skills.

  • Strong analytical and problem-solving skills.

  • Ability to work independently and manage multiple priorities.

Physical Requirements:

  • Travel – 15-40% (mostly in APAC, but some global)

  • Off-hour meetings with Global Teams based in North America – 10-15%

  • On site role (based out of our factory in Johor Bahru, Malaysia)

Buat amaran kerja untuk carian ini

Senior Manager, Supplier Quality APAC • Gelang Patah, Johor

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