Sr Quality Engineer, Supplier Quality Engineering

21 DexCom Malaysia Sdn Bhd; Penang; On-site; MYR 100,000 - 167,000; Full time

Job summary

Dexcom Malaysia is seeking a Supplier Quality professional to design and maintain the supplier quality system, guide other departments, and lead supplier audits. You will monitor supplier performance, manage CAPA, and support internal/external audits to ensure compliance with medical device standards.

The role emphasizes cross-functional collaboration, data-driven decision making, and continuous improvement to deliver safe, high-quality medical products.

Qualifications

• Experience with established quality systems regulations (e.g., ISO 13485, 21 CFR Part 820)
• Track record of leading supplier audits and cross-functional investigations
• Ability to mentor junior engineers in quality methodologies

Responsibilities

• Design and maintain supplier quality management system per policies.
• Provide quality guidance to other departments.
• Perform supplier qualification audits and monitor performance, reports, and CAPA.
• Attend and support internal audits by regulatory bodies and external agencies.
• Chair Supplier Review meetings and maintain transparency across teams.

Skills

Quality systems

Audits

Supplier management

Problem solving

Education

Quality auditing certification (preferred)

Tools

Oracle

SAP

Minitab

Job description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing‑technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Meet the team:

The Supplier Quality department plays a critical and strategic role in ensuring that all externally sourced components and materials meet the stringent quality and regulatory standards required within the medical industry. This position directly contributes to product reliability, patient safety, and overall supply chain integrity by partnering with global suppliers, driving quality performance, and facilitating continuous improvement initiatives. Our team is committed to operational excellence, data‑driven decision‑making, and strong cross‑functional collaboration. We offer an environment where professionalism, accountability, and technical expertise are highly valued, while also fostering a culture of respect, learning, and shared success. Candidates joining this team will have the opportunity to influence key quality processes, strengthen supplier partnerships, and support the development of safe and effective medical products. This is a meaningful career path for individuals who are dedicated, detail‑oriented, and passionate about contributing to high‑quality patient outcomes.

Where you come in:

• You will design and maintain supplier quality management system according to written policies and procedures.
• You will provide quality guidance to other departments.
• You will perform supplier qualification audits, monitor supplier performance, provide supplier program metrics and periodic reports, and manage supplier corrective action system.
• You will establish and maintain Supplier Audit Schedule and ensure compliance with the schedule.
• You will attend and support internal audits by regulatory and other outside agencies.
• You will serve as supplier quality representative during internal audits and for designated suppliers, as necessary.
• You could travel in the U.S. and internationally.
• You will chair the Supplier Review meetings and ensure ongoing supplier program transparency and open communication between cross-functional departments.
• You will establish and maintain supplier Quality Agreements, where needed, and any joint periodic supplier business reviews.
• You will review and approve supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreement.
• You may work as a member of the design team, as required.
• Some type of activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
• You have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics: utilizing these techniques as appropriate per Dexcom and/or industry recognized standards.
• You will provide training and guidance to lower-level quality engineers and new hires.
• You will take the initiative to develop systems and process improvements that: increase product safety; increase product consistency and conformance to requirements; improve production efficiency and communication; reduce operating and scrap costs.
• You read, write and understand specifications and inspection criteria.
• You read schematics and mechanical drawings and provide input into revisions as needed.
• You work and communicate effectively and professionally in a team environment with minimal supervision.
• You apply proficient computer skills in the use of Microsoft Office and database applications (such as Oracle, SAP and Minitab).
• You understand able to revise Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA) if necessary.
• You possess knowledge of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards including ISO 13485.
• You’re training and/or certification to perform quality audits is highly desired.
• Your experience with supplier quality programs is highly desired.
• You will assume and perform other duties as assigned.

What makes you successful:

Demonstrated mastery of structured problem‑solving methodologies (e.g., 8D, 5 Why, Ishikawa), with a proven track record of leading complex cross‑functional investigations and driving sustainable corrective actions.

Extensive experience in conducting and leading suppliers, certification, and regulatory compliance audits, with the ability to assess risk, identify systemic gaps, and influence improvement at an organizational level.

Strong understanding of end‑to‑end manufacturing processes, preferably including molding, metal processing (stamping, welding, chemical grinding), ultrasonic cleaning/welding, SMT operations, and power electronics production, enabling effective technical discussions and supplier capability assessments.

Highly proficient in data‑driven decision‑making, with the ability to independently identify issues, analyze trends, and drive strategic quality initiatives as a self‑starter.

Exceptional communication and stakeholder management skills, with the ability to influence suppliers, internal leadership, and cross‑functional teams to align on quality expectations and improvement plans.

Proven expertise in applying and interpreting advanced quality tools such as APQP, PPAP, SPC, MSA, and FMEA, including the ability to mentor others in structured quality methodologies.

Knowledge of Good Documentation Practices (GDP), with the capability to reinforce compliance and documentation excellence across teams.

Deep understanding of ISO 13485 or comparable regulated quality management systems, with the ability to guide teams in maintaining compliance and audit readiness.

Certification or formal training in quality auditing, demonstrating readiness to lead audits and influence quality culture throughout the organization.

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide.

At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.