What are the responsibilities and job description for the Senior Supplier Quality Engineer position at System One?
Title: Senior Supplier Quality Engineer
Location: On-site, Lakewood, CO
Schedule: M-F 9:00am- 5:00pm-, hybrid 3 days required to be onsite
Pay: $107,000-$133,800k, 7% bonus (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, with a focus on injection molding, blow molding, and high-speed automation. This role is responsible for ensuring supplier quality performance, driving improvements, and supporting 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
- 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
#M3
Ref: #558-Scientific
Salary : $107,000 - $133,800