Cypress HCM · 2 weeks ago
Supplier Quality Engineer
Twin Cities Area
Contract
Onsite
Mid Level
$90K/yr - $105K/yr
4+ years expCypress HCM is seeking a Supplier Quality Engineer who will lead supplier quality issue resolution and drive continuous improvement for medical devices. This role involves partnering with suppliers and cross-functional teams to ensure compliance with FDA and ISO requirements, while addressing nonconformances and implementing corrective actions.
Human ResourcesInformation TechnologyStaffing Agency
Responsibilities
Lead investigation and resolution of supplier-related quality issues impacting product and manufacturing performance
Drive supplier corrective actions using risk-based and data-driven quality tools
Conduct supplier assessments, audits, and reviews to evaluate capability and compliance
Evaluate supplier changes for impact to design, quality, and regulatory requirements
Develop and maintain receiving inspection criteria and supplier quality documentation
Support internal and external audits and regulatory inspections
Collaborate cross-functionally with Manufacturing, R&D, and Supply Chain teams
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related technical field
4+ years of supplier quality experience in the medical device industry
Working knowledge of FDA 21 CFR Part 820 and ISO 13485 (AS9100 acceptable)
Experience resolving supplier nonconformances and leading corrective actions
Hands-on experience with electromechanical components or systems
Strong organizational, analytical, and communication skills
Comfortable working directly with suppliers in a hands-on quality role
Company
Cypress HCM
Cypress HCM is a staffing and recruiting company providing technology and creative recruiting solutions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Mark Lillig
CEO
Philip Oommen
CFO
Company data provided by crunchbase