Title: Supplier Quality Engineer
Location: Lakewood, CO

Position Overview: Our client in Lakewood CO is seeking a highly skilled and experienced Supplier Quality Engineer to join their dynamic team. The ideal candidate will have a strong background in supplier quality management within the medical device industry. This role is crucial in ensuring that our suppliers consistently deliver high-quality components and materials that meet regulatory requirements and company standards.

Responsibilities:

• Develop and implement supplier quality management programs and processes in accordance with industry standards and regulations (e.g., ISO 13485, FDA QSR).
• Conduct supplier audits and assessments to evaluate their quality systems, manufacturing processes, and capabilities.
• Collaborate with suppliers to resolve quality issues, implement corrective and preventive actions (CAPAs), and drive continuous improvement.
• Review and approve supplier documentation including quality agreements, specifications, and change notifications.
• Perform risk assessments on suppliers and their products to mitigate quality and compliance risks.
• Support supplier selection and qualification processes by providing quality engineering expertise and ensuring supplier compliance.
• Participate in cross-functional teams to address supplier-related issues and support new product development and product lifecycle management activities.
• Monitor supplier performance metrics and develop reports to communicate quality issues and improvements to management.

Qualifications:

• Bachelor's degree in Engineering or related technical field required; advanced degree preferred
• Minimum of 6 years of experience in Supplier Quality Engineering, preferably in the medical device industry.
• Strong knowledge of quality management systems, regulatory requirements (e.g., FDA, ISO), and industry standards.
• Experience conducting supplier audits and assessments using recognized industry standards (e.g., ISO 9001).
• Proven track record in supplier development, qualification, and management.
• Excellent problem-solving skills and ability to lead root cause analysis and corrective action processes.
• Effective communication skills with the ability to collaborate across functions and influence stakeholders.
• Willingness to travel domestically and internationally as required.

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