System One
Title:
Senior Supplier Quality Engineer Location:
On-site, Lakewood, CO Schedule:
M-F 9:00am-5:00pm, hybrid 3 days onsite required Pay:
$107,000-$133,800, 7% bonus, excellent healthcare benefits, unlimited PTO, relocation assistance Type:
Direct/Permanent Start date:
Immediate Overview:
Our client, a global medical device company, is seeking a Senior Supplier Quality Engineer to support contract manufacturers and key suppliers, focusing on injection molding, blow molding, and high-speed automation. This role ensures supplier quality performance, drives improvements, and supports new product introductions and validations in a regulated manufacturing environment. Responsibilities:
Act as the primary quality contact for CMOs, managing quality and technical issue resolution Work cross-functionally on supplier quality efforts including performance monitoring, process development, tooling and component validations, and CAPAs Support new product introductions (NPI) and drive supplier readiness for production Lead or contribute to project management efforts across supplier quality initiatives Participate in supplier selection, audits, and evaluations Ensure compliance with FDA and global regulatory requirements Provide technical input on risk management, process design, and test method validation Guide and mentor team members, promote collaboration, and support technical problem solving across teams Requirements:
Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or related) Minimum 6 years of engineering experience, including: At least 2 years in GMP manufacturing At least 4 years in injection molding, blow molding, or device manufacturing at contract manufacturers Strong understanding of supplier quality systems, validations, and regulatory standards Project management experience and the ability to lead cross-functional initiatives The company offers competitive total rewards including compensation, benefits, recognition, and well-being programs to support personal and family welfare. Benefits include multiple medical, dental, and vision plans, wellness programs, life insurance, disability coverage, voluntary programs, a 401(k) plan with matching, and vacation and sick leave. We prioritize protecting our associates' personal welfare and supporting their personal goals.
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Senior Supplier Quality Engineer Location:
On-site, Lakewood, CO Schedule:
M-F 9:00am-5:00pm, hybrid 3 days onsite required Pay:
$107,000-$133,800, 7% bonus, excellent healthcare benefits, unlimited PTO, relocation assistance Type:
Direct/Permanent Start date:
Immediate Overview:
Our client, a global medical device company, is seeking a Senior Supplier Quality Engineer to support contract manufacturers and key suppliers, focusing on injection molding, blow molding, and high-speed automation. This role ensures supplier quality performance, drives improvements, and supports new product introductions and validations in a regulated manufacturing environment. Responsibilities:
Act as the primary quality contact for CMOs, managing quality and technical issue resolution Work cross-functionally on supplier quality efforts including performance monitoring, process development, tooling and component validations, and CAPAs Support new product introductions (NPI) and drive supplier readiness for production Lead or contribute to project management efforts across supplier quality initiatives Participate in supplier selection, audits, and evaluations Ensure compliance with FDA and global regulatory requirements Provide technical input on risk management, process design, and test method validation Guide and mentor team members, promote collaboration, and support technical problem solving across teams Requirements:
Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or related) Minimum 6 years of engineering experience, including: At least 2 years in GMP manufacturing At least 4 years in injection molding, blow molding, or device manufacturing at contract manufacturers Strong understanding of supplier quality systems, validations, and regulatory standards Project management experience and the ability to lead cross-functional initiatives The company offers competitive total rewards including compensation, benefits, recognition, and well-being programs to support personal and family welfare. Benefits include multiple medical, dental, and vision plans, wellness programs, life insurance, disability coverage, voluntary programs, a 401(k) plan with matching, and vacation and sick leave. We prioritize protecting our associates' personal welfare and supporting their personal goals.
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