Supplier Quality Engineer (Electronics)

Insulet; Gelang Patah; On-site; MYR 80,000 - 100,000; Full time

Job summary

A leading medical device company in Malaysia is seeking a Supplier Quality Engineer to ensure supplier governance and quality systems. This role involves developing performance indicators, leading root cause analyses, and engaging with suppliers for improved performance. Candidates should have a Bachelor's degree in Electronics Engineering or related, alongside at least 5 years of experience in supplier quality within the medical device sector. Strong analytical and communication skills are essential for this dynamic role.

Qualifications

• Strong understanding of quality management systems and regulatory frameworks.
• Ability to analyze quality data and generate actionable insights.
• Experience with electronics manufacturing processes and supplier performance.

Responsibilities

• Ensure supplier governance and quality systems.
• Develop and monitor key performance indicators.
• Lead root cause analysis for supplier-related issues.

Skills

Electronics manufacturing processes

Problem solving

Analytical capabilities

Verbal communication

Teamwork

Education

Bachelor's degree in Electronics Engineering or related field

Minimum 5 years of experience in medical device supplier quality

Job description

Insulet started in 2000 with an idea and a mission Kne 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 with 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 and to build our Center of Excellence and be at the forefront of our rapidly growing global footprint.

Job Title

Supplier Quality Engineer – Electronics江苏

Position Overview

Supplier Quality Engineer is responsible for ensuring supplier governance and governance of related quality systems. The Engineer creates, monitors, and reports on metrics that show the health and capability of the supplier quality system. The individual maintains records and databases needed for those metrics. The Engineer ensures current products and new projects meet quality and regulatory requirements for medical devices. The Engineer interfaces with other Insulet departments (e.g. Senior Management, Manufacturing Operations, Production Operations, Supplier Development Engineering, Design Engineering, Information Technology, Engineering, Procurement, New Business Development and Regulatory Affairs) as well as suppliers, contractors and other external parties on issues related to supplier quality, quality management systems, materials, product support and external and internal audit support. Effectively communicating supplier quality performance metrics, status and requirements are critical to the success of the position. Other significant impacts will come from collaborating on the selection of qualified suppliers, leading the efforts to quantify and improve supplier performance, and providing a positive impact on the quality of new and existing products through a global footprint.

Responsibilities

• Responsible for supplier quality engineering (SQE) deliverables to support Electronics category sourcing strategies and continuity of production.
• Solid knowledge or expertise of electronics manufacturing processes and in problem solving related to manufacturing processes of PCBAs, PCBs and electronic sub‑assemblies. Strong understanding of Surface Mount Technology (SMT), In‑Circuit Testing (ICT), Functional Circuit Testing (FCT) and reliability testing.
• Develop and monitor key performance indicators (KPIs) and other metrics.
• Develop and deploy dashboards and other visualizations required to support metrics. Develop risk management strategies to mitigate product and compliance risks.
• Lead SQE efforts in sustaining projects to accomplish primary objectives, including cost reduction, capacity increase, dual sourcing and risk mitigation.
• Engage partnerships with suppliers (including sub‑tiers) and supply chain management (SCM) to drive superior supplier performance and accountability.
• Experience in supplier selection, supplier production part approval process (PPAP), DOE, process capability analysis, G R&R, control plan, SPC and inspection procedure development.
• Experience in supplier performance monitoring and improvement.
• Lead root cause analysis of supplier‑related non‑conforming product issues to address and resolve quality concerns via Supplier Corrective Action Report (SCAR). Drive corrective action and supplier improvement activities that directly impact performance for assigned suppliers.
• Coordinate review, technical assessment and documentation for supplier change requests.
• Ability to set goals with a proactive approach to complete assignments in a timely, effective and high‑quality manner.
• Ability to work in bmi team‑oriented and fast‑paced environment.
• Excellent communicator for complex problems, execution plan, progress report out, and escalation to supplier quality leadership and all levels in the organization.

Required Leadership/Interpersonal Skills & Behaviors

• Demonstrates agility and responsiveness to evolving quality challenges.
• Effectively influences internal cross‑functional teams and external suppliers to drive resolution and improvements.
• Demonstrates a strong customer‑centric mindset. Builds strong cross‑functional partnerships across Engineering, Operations and Account Management.
• Excellent analytical capabilities and problem‑solving skills.
• Communicates clearly, concisely and persuasively across all organizational levels.
• Possesses exceptional skill in handling competing priorities and requirements, especially with external entities. Adept at driving consensus and action, culminating in clear communication.
• Ability to work in a team‑oriented, high energy and fast‑paced environment.

Required Skills and Competencies

• Strong understanding of QMS systems, complaint handling and regulatory framework (21 CFR Part 820, Part 11 and IPC‑A‑610 standard).
• Exceptional organizational skills and attention to detail.
• Excellent written and verbal communication abilities.
• Professional handling of confidential and sensitive information.
• Proficiency in analyzing quality data and generating actionable insights through dashboards or reports.

Education and Experience

• Bachelor’s degree in Electronics Engineering or in a related field or equivalent.
• Minimum 5 years of progressive work experience in medical device supplier quality, quality, manufacturing or engineering.
• Experience working with electronics manufacturing.

Additional Information

• This position is based at our Malaysia site.
• Estimated travel: ~25%, with flexibility based on business needs.