Deskripsi Pekerjaan
Join a global leader in medical technology as a Supplier Quality Engineer in the dynamic industrial hub of Penang. In this critical role, you will serve as the guardian of our supply chain integrity, ensuring that all incoming materials meet rigorous quality standards before they reach our production lines. We are seeking a detail-oriented and proactive professional to oversee the quality performance of our suppliers, driving continuous improvement initiatives and resolving complex quality issues to support our mission of advancing patient health.
You will act as the primary point of contact for quality-related matters with our vendors, utilizing your expertise to foster long-term, mutually beneficial supplier relationships. By implementing robust quality control strategies and ensuring strict adherence to regulatory standards, you will play a vital role in minimizing risk and maximizing product excellence for patients worldwide.
You will act as the primary point of contact for quality-related matters with our vendors, utilizing your expertise to foster long-term, mutually beneficial supplier relationships. By implementing robust quality control strategies and ensuring strict adherence to regulatory standards, you will play a vital role in minimizing risk and maximizing product excellence for patients worldwide.
Tanggung Jawab
- Oversee incoming material quality and monitor key supplier performance metrics.
- Conduct on-site supplier audits and process validation activities.
- Investigate and manage Non-Conformance Reports (NCRs) with a focus on root cause analysis.
- Develop and maintain Supplier Quality Agreements (SQAs) and Control Plans.
- Collaborate with cross-functional teams (R&D, Operations, Supply Chain) to resolve quality bottlenecks.
- Ensure full compliance with ISO 13485, ISO 9001, and relevant regulatory requirements.
- Drive continuous improvement projects to enhance supplier capabilities.
Kualifikasi
- Bachelor’s degree in Mechanical, Chemical, Industrial, or Electrical Engineering.
- Minimum of 3-5 years of experience in Supplier Quality or Manufacturing Engineering.
- Experience within the medical device or life sciences industry is highly preferred.
- Strong working knowledge of quality tools such as APQP, PPAP, FMEA, and MSA.
- Excellent problem-solving skills and the ability to communicate complex technical information effectively.
- Proficiency in Microsoft Office Suite and ERP systems.