Sr. Supplier Quality Engineer

Custom Search Inc.; Maple Grove (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

Custom Search Inc. is seeking a Supplier Quality Engineer to strengthen supplier quality management for externally sourced components and materials used in medical devices.

You will collaborate with suppliers and cross‑functional teams to address nonconformances, lead corrective actions, and support continuous improvement initiatives. You will conduct supplier audits to ensure compliance with quality systems, assist in supplier qualification, and ensure incoming components meet specifications

Qualifications

• Bachelor’s degree in Engineering, Quality, or related technical discipline.
• 2–5 years of experience in Supplier Quality or Quality Engineering.
• Experience managing supplier corrective actions and supplier audits.
• ASQ Certified Quality Auditor (CQA) or Supplier Quality certification preferred.

Responsibilities

• Lead supplier corrective action requests (SCAR/SAR) and ensure timely closure of supplier issues.
• Investigate and resolve supplier-related nonconformances.
• Partner with suppliers to drive root cause analysis and corrective actions.
• Monitor supplier performance and support supplier quality improvement initiatives.

Skills

Supplier quality management

Root cause analysis

Education

Bachelor’s degree in Engineering, Quality, or related technical discipline

Job description

Our client, a growing medical device company, is seeking a Supplier Quality Engineer to support supplier quality management activities and ensure the quality and compliance of externally sourced components and materials.

This role will work closely with suppliers and internal cross-functional teams to address supplier nonconformances, drive corrective actions, and ensure suppliers meet regulatory and quality system requirements. The ideal candidate will enjoy working in a hands-on environment, collaborating with suppliers, and supporting continuous improvement initiatives.

Your role with the company:

Supplier Quality Management

• Lead supplier corrective action requests (SCAR/SAR) and ensure timely closure of supplier issues.

• Investigate and resolve supplier-related nonconformances.

• Partner with suppliers to drive root cause analysis and corrective actions.

• Monitor supplier performance and support supplier quality improvement initiatives.

Auditing & Compliance

• Conduct supplier audits to ensure compliance with quality system requirements.

• Support supplier qualification and ongoing supplier evaluations.

• Assist in the development and maintenance of supplier quality agreements.

Incoming Inspection & Quality Support

• Support incoming inspection processes and ensure supplier components meet specifications.

• Work cross-functionally with engineering, manufacturing, and quality teams to resolve supplier issues.

• Ensure supplier processes align with ISO 13485 and medical device regulatory requirements.

Continuous Improvement

• Participate in supplier quality improvement projects.

• Support risk management and supplier performance monitoring activities.

• Assist with supplier-related documentation and quality system processes.

Desired Profile:

• Bachelor’s degree in Engineering, Quality, or related technical discipline

• 2–5 years of experience in Supplier Quality or Quality Engineering

• Experience working in the medical device industry preferred

• Experience managing supplier corrective actions and supplier audits

• Familiarity with incoming inspection processes and supplier nonconformance management

• ASQ Certified Quality Auditor (CQA) or Supplier Quality certification (preferred)

Skills & Competencies

• Strong understanding of supplier quality management principles

• Knowledge of ISO 13485 and medical device quality systems

• Strong root cause analysis and problem-solving skills

• Ability to work cross-functionally with suppliers and internal teams

• Comfortable working in fast-paced environments where employees wear multiple hats