Job Summary We are seeking a
Supplier Quality Engineer to support supplier quality management, incoming material quality, nonconformance investigations, risk assessment, and continuous improvement activities. The role will work closely with Quality, Operations, Engineering, and external suppliers to identify and resolve quality issues, improve supplier performance, and ensure compliance with applicable quality and regulatory requirements. Experience in a regulated industry, particularly medical devices, is highly desirable.
Roles and Responsibilities - Investigate, analyze, and resolve supplier-related quality issues and material nonconformances.
- Conduct risk assessments and support root cause analysis and corrective/preventive action activities.
- Monitor supplier quality performance and develop improvement initiatives.
- Support incoming inspection, incoming material quality, and supplier quality controls.
- Collaborate with suppliers to implement corrective actions and prevent recurrence of quality issues.
- Partner with Quality, Operations, Engineering, and other cross-functional teams to address quality concerns.
- Review and maintain supplier quality records, reports, and other required documentation.
- Ensure quality activities are performed in accordance with internal procedures, quality standards, and applicable regulatory requirements.
- Support supplier audits, assessments, and ongoing supplier performance management as required.
- Identify opportunities for continuous improvement in supplier processes and quality systems.
- Communicate quality issues, investigation findings, corrective actions, and improvement plans effectively to internal and external stakeholders.
Education and Experience - Bachelor's degree in engineering, Quality, Manufacturing, or a related technical discipline
- 3+ years of experience in Quality Engineering, Supplier Quality Engineering, or a related quality function.
- Experience working with suppliers, incoming material quality, nonconformance investigations, and root cause analysis.
- Experience in a regulated industry is preferred.
- Medical device industry experience is a plus.
- Familiarity with ISO 13485 and medical device quality system requirements.
