Deskripsi Pekerjaan
Are you ready to make a tangible impact on global healthcare? Boston Scientific is seeking a dynamic and experienced Principal Supplier Engineer to join our dedicated team in Penang. As a global leader in medical technology, we are committed to advancing science for life, and your role will be pivotal in ensuring the highest standards of quality and efficiency across our supply chain.
In this senior-level position, you will serve as the technical authority for supplier quality, leading the resolution of complex non-conformances and driving initiatives to achieve significant material cost reduction targets. You will work at the intersection of engineering, supply chain management, and regulatory compliance, ensuring that our products meet the exacting standards required for patient safety. If you are a strategic thinker with a passion for quality excellence and want to contribute to life-saving technologies, this is the opportunity for you.
We offer a collaborative environment where your expertise will directly influence our operational success and market leadership.
Tanggung Jawab
- Technical Leadership: Lead the technical investigation and resolution of non-conformances within the supply chain, ensuring root causes are identified and permanent corrective actions are implemented.
- Cost Reduction: Drive material cost reduction strategies by collaborating with suppliers to optimize processes, reduce waste, and improve material efficiency.
- Quality Management: Oversee the implementation and maintenance of Quality Management Systems (QMS) for key suppliers, ensuring compliance with ISO 13485 and FDA regulations.
- Process Improvement: Utilize tools such as APQP, PPAP, and FMEA to support new product introductions (NPI) and process validation with manufacturing partners.
- Supplier Performance: Monitor supplier performance metrics and conduct regular audits to drive continuous improvement and mitigate supply chain risks.
- Collaboration: Partner with cross-functional teams, including R&D, Procurement, and Manufacturing, to address technical challenges and align on quality goals.
Kualifikasi
- Education: Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or Manufacturing preferred).
- Experience: Minimum of 5-8 years of experience in Supplier Quality Engineering, Supplier Development, or a related role within the medical device or manufacturing industry.
- Regulatory Knowledge: In-depth understanding of quality standards such as ISO 13485, IEC 62366, and FDA QSR (21 CFR Part 820).
- Methodology: Strong working knowledge of quality tools and methodologies, including 8D problem solving, 5 Whys, and statistical analysis.
- Communication: Excellent verbal and written communication skills, with the ability to influence stakeholders at all levels of the organization.
- Technical Skills: Proficiency in using quality management software and data analysis tools (e.g., Minitab, JMP).