Quality Engineer 2

Cypress HCM; Minneapolis (MN); On-site; USD 90,000 - 105,000; Full time

Job summary

A leading healthcare recruitment firm is seeking a Supplier Quality Engineer II in Minneapolis, MN. This in-person role focuses on resolving supplier quality issues and ensuring compliance in the medical device sector. You will drive continuous improvement and collaborate with cross-functional teams to evaluate and document supplier performance. Ideal candidates will have a Bachelor's degree in engineering or life sciences and over 4 years of relevant experience. Competitive pay rate between $90,000 and $105,000 annually.

Qualifications

• Minimum 4 years of supplier quality experience in the medical device industry.
• Professional knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience in resolving supplier nonconformances.

Responsibilities

• Lead investigation and resolution of quality issues.
• Drive corrective actions using data-driven tools.
• Conduct supplier assessments to evaluate compliance.

Skills

Supplier quality experience

FDA compliance knowledge

Strong organizational skills

Analytical skills

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Overview

This in-person role is responsible for leading supplier quality issue resolution and driving continuous improvement to ensure consistent component and material performance for medical devices. The Supplier Quality Engineer II partners closely with suppliers and cross-functional teams to investigate nonconformances, implement corrective actions, and ensure compliance with FDA and ISO requirements.

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

Qualifications

• 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

Pay Rate

• $90-105k