Sr Quality Engineer, Supplier Quality Engineering

Dexcom Inc.; Penang; On-site; MYR 70,000 - 95,000; Full time

Job summary

Dexcom Inc. is looking for a dedicated Supplier Quality Engineer in Penang, Malaysia. This role will involve managing supplier quality systems, conducting audits, and ensuring compliance with quality standards.

Successful candidates will possess a strong background in quality systems, excellent problem-solving skills, and the capacity to work collaboratively across departments. If you are passionate about ensuring high-quality patient outcomes and thrive in a regulated environment, we'd love to hear from you.

Qualifications

• Demonstrated mastery of structured problem-solving methodologies.
• Extensive experience in conducting and leading supplier audits.
• Strong understanding of end-to-end manufacturing processes.

Responsibilities

• Design and maintain supplier quality management system.
• Perform supplier qualification audits and monitor performance.
• Provide quality guidance to other departments.

Skills

Structured problem-solving methodologies

Supplier quality programs

Communication skills

Data-driven decision making

Quality auditing techniques

Education

Certification in quality auditing

Knowledge of ISO 13485

Tools

Microsoft Office

Oracle

SAP

Minitab

Job description

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.