Deskripsi Pekerjaan
Are you passionate about ensuring the highest standards of quality in the medical device industry? Dexcom is seeking a dedicated Quality Engineer 2 to join our Supplier Quality Engineering team in Batu Kawan. In this critical role, you will be responsible for ensuring that all external sourced components and materials meet the stringent quality and regulatory standards required in the medical device sector. You will act as a vital bridge between Dexcom and our suppliers, driving continuous improvement and mitigating quality risks to ultimately benefit patient care.
As part of our Supplier Quality Engineering team, you will lead initiatives to enhance supplier performance, ensure regulatory compliance, and foster a culture of quality throughout the supply chain. You will be exposed to cutting-edge continuous glucose monitoring (CGM) technology and have the opportunity to make a tangible impact on global health.
Tanggung Jawab
- Manage and execute supplier quality audits, assessments, and qualification activities to ensure compliance with Dexcom and regulatory standards.
- Investigate and resolve supplier non-conformance (NC) issues, leading root cause analysis and CAPA (Corrective and Preventive Action) implementation.
- Monitor supplier performance metrics and Key Performance Indicators (KPIs) to drive continuous improvement.
- Develop and maintain Supplier Quality Agreements (SQAs) and quality requirements.
- Ensure all incoming materials and components meet quality specifications and regulatory requirements (ISO 13485, FDA).
- Collaborate with cross-functional teams including R&D, Manufacturing, and Procurement to resolve quality concerns.
- Conduct training sessions for suppliers on quality systems and process improvements.
Kualifikasi
- Bachelor’s Degree in Engineering (Mechanical, Electrical, Industrial, or Chemical) or a related field.
- Minimum of 3-5 years of experience in Quality Engineering, Supplier Quality, or Manufacturing Quality.
- Strong knowledge of medical device regulations, including ISO 13485, IEC 62366, and FDA QSR.
- Experience with quality tools such as APQP, PPAP, FMEA, and SPC.
- Excellent analytical and problem-solving skills with a detail-oriented approach.
- Strong communication and interpersonal skills, with the ability to influence suppliers effectively.
- Willingness to travel to supplier sites as required.