Supplier Quality Engineer

Job Summary

As a Supplier Quality Engineer, you will play a critical role in ensuring the quality and reliability of products manufactured by our suppliers. You will work closely with our suppliers, cross-functional teams, and internal quality assurance teams to establish and maintain robust supplier quality management processes. Your primary responsibility will be to assess, monitor, and improve the quality of components, materials, and services provided by our suppliers to meet the company's quality standards and customer expectations.

Primary Responsibilities:

• Supplier Assessment and Selection: o Conduct supplier assessments and audits to evaluate their capabilities, quality systems, and compliance with industry standards and regulations.
• Collaborate with the necessary departments to select new suppliers based on their quality and technical capabilities.
• Supplier Quality Management: o Develop, implement, and maintain supplier quality agreements and contracts, outlining quality expectations and requirements.
• Monitor supplier performance regularly using key performance indicators (KPIs) and quality metrics. oIdentify and mitigate quality issues, non-conformities, and deviations in supplier processes or products.
• Collaborate with suppliers to establish and complete corrective and preventive action (CAPA) plans to address quality issues and drive continuous improvement.
• Supplier Development: o Work closely with suppliers to improve their quality systems, processes, and capabilities.
• Provide guidance and support to suppliers in implementing best practices and quality improvement initiatives.
• Documenting and Reporting: o Maintain accurate records of supplier audits, assessments, and quality data.
• Generate and present regular reports on supplier performance, trends, and improvement initiatives to management and relevant stakeholders.
• CrossFunctional Collaboration: o Collaborate with internal teams across the organization to align supplier quality objectives with overall business goals.
• Regulatory Compliance o Ensure that suppliers adhere to relevant industry standards and regulatory requirements.
• Stay updated on changes in quality and regulatory standards that may affect supplier quality.
  
  

Qualification and Skills:

• Bachelor's degree in engineering or a related field; advanced degree preferred. oMinimum 5 years of experience in supplier quality engineering or a related role, with a strong track record of supplier development and quality improvement in a highly regulated industry (Medical Devices preferred)
• In-depth knowledge of quality management systems, such as ISO 9001, ISO 13485, and 21 CFR820. oCertified as Lead Auditor for ISO 13485.
• Strong analytical, problem-solving, and statistical analysis skills. oExcellent communication and interpersonal skills to build effective relationships with suppliers and internal teams.
• Project management skills and the ability to manage multiple tasks simultaneously.
• Some Travel required
  
  

A Supplier Quality Engineer plays a crucial role in ensuring the reliability of the supply chain and the overall quality of products delivered to customers. This position requires a combination of technical expertise, strong interpersonal skills, and a commitment to continuous improvement.