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Supplier Quality Engineer
2 months ago
Job Description:
We are seeking a detail-oriented Supplier Quality Engineer with 3 to 5 years of experience to join our team. In this role, you will manage nonconforming materials from suppliers, collaborate with cross-functional teams on the Material Review Board (MRB) process, and drive supplier performance improvements. You will play a critical role in ensuring the quality and reliability of materials supplied to our manufacturing processes by investigating quality issues, identifying corrective actions, and contributing to continuous improvement initiatives.
Key Responsibilities:
- Manage nonconforming materials and lead the Material Review Board (MRB) process to address supplier-related quality issues.
- Investigate supplier quality issues and collaborate on root cause analysis, corrective actions, and CAPA implementation.
- Monitor supplier performance and work closely with suppliers to resolve quality issues and drive continuous improvement initiatives.
- Participate in and contribute to quality improvement projects aimed at enhancing part quality, yields, and cost efficiency.
- Review and interpret engineering drawings and specifications, particularly in areas like printed circuit boards, pumps, motors, and other mechanical parts.
- Ensure compliance with ISO 13485, FDA, GMP, or ISO 9001 standards, and contribute to quality audits as needed.
- Utilize ERP systems like ADMS or SAP to analyze data and monitor supplier performance.
- Collaborate with cross-functional teams to support new product introductions and ensure supplier quality alignment with company standards.
Qualifications:
- Bachelor's degree in Mechanical, Biomedical, Industrial Engineering, or a related field.
- 3-5 years of experience in a supplier quality role within a manufacturing environment.
- Experience with quality tools and processes such as CAPA, MRB, and quality holds.
- Knowledge of ISO 13485, FDA, GMP, or ISO 9001 standards.
- Ability to interpret engineering drawings and specifications for components like circuit boards, pumps, motors, and other mechanical parts.
Skills:
- Proficiency in ERP systems (preferably ADMS or SAP).
- Strong working knowledge of Microsoft Office, particularly Excel, for data analysis and reporting.
- Experience in managing supplier quality, conducting root cause analysis, and implementing corrective actions.
- Strong understanding of quality standards, particularly ISO 13485, FDA, GMP, or ISO 9001.
- Excellent communication and problem-solving skills, with the ability to work collaboratively in cross-functional teams.
