System One
Supplier Quality Engineer III
System One, Denver, Colorado, United States, 80285
Title:
Supplier Quality Engineer IIILocation:
Lakewood, COSchedule:
Hybrid 2-3 days on sitePay: $107,000 - $133,800 - 7% Bonus
Position Overview:
Our client in Lakewood CO is seeking a highly skilled and experienced Supplier Quality Engineer to join theirdynamic 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.
The company provides competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
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Supplier Quality Engineer IIILocation:
Lakewood, COSchedule:
Hybrid 2-3 days on sitePay: $107,000 - $133,800 - 7% Bonus
Position Overview:
Our client in Lakewood CO is seeking a highly skilled and experienced Supplier Quality Engineer to join theirdynamic 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.
The company provides competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.
#M3#J-18808-Ljbffr