Supplier Quality Engineer II

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$95,000.00/yr - $/yr

Job Title
:
Supplier Quality Engineer II

Department
:
Quality

Reports to
:
Quality Manager

Work Location
:
In-Person

Pay Range
:
Based on Experience - $95,000.00 to $

Position Type and Expected Hours of Work
:
Full-Time, Monday-Friday, 40 hours/week

Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.

The Supplier Quality Engineer II leads the resolution of supplier quality issues to ensure consistent component and material performance. This role collaborates with suppliers, manufacturing, development, and supply chain teams to investigate nonconformances, implement corrective actions, and drive continuous improvement. Additional responsibilities include conducting supplier assessments, maintaining compliant documentation, and ensuring adherence to FDA 21 CFR Part 820 and ISO 13485 standards.

None

• Investigate and resolve supplier-related issues that impact product quality, manufacturing, or business performance.
• Apply quality tools and methodologies to drive supplier performance and support Elucent’s supply chain objectives.
• Lead supply chain quality activities, including supplier assessments, component selection, data analysis, and preparation of technical documentation.
• Evaluate supplier changes for potential effects on design, quality, and regulatory compliance for manufacturing and development projects.
• Collaborate with suppliers through meetings, audits, and reviews to identify risks, drive corrective actions, and improve quality outcomes.
• Develop, maintain, and improve receiving inspection and process documentation to ensure consistency and compliance.
• Support decisions affecting product safety, quality, and customer satisfaction using data-driven and risk-based approaches.
• Participate in internal and external audits and regulatory inspections to maintain compliance with applicable standards.

Education and Experience

• Minimum of 4 years’ experience in Supplier Quality within the medical device industry
• Bachelor’s degree (BA/BS) in engineering, life sciences, or related technical field
• Working knowledge of medical device quality management systems, including 21 CFR Part 820 and ISO 13485; experience with AS9100 acceptable
• Demonstrated experience in supplier quality activities, including issue resolution, assessments, component validation, and statistical analysis.
• Proficiency with standard office and quality/design engineering software tools
• Must be comfortable with a hands‑on approach to supplier quality.
• Excellent organizational and time management skills
• Experience working with electromechanical medical devices or systems is required.

Required Skills/Abilities

Leadership

• Serves as a technical representative in supplier quality, guiding teams through the application of supplier controls, risk management, and verification/validation activities.
• Leads or supports product development initiatives by identifying and resolving supplier quality assessments, issues, while ensuring compliance with applicable regulatory requirements and internal procedures.
• Collaborates effectively on cross‑functional teams to define and implement robust supplier quality assurance strategies that align with quality system requirements and support product safety and effectiveness.

Communication

• Excellent written and oral communication skills
• Ability to formulate responses to common inquiries from suppliers, customers, and regulatory agencies.
• Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give presentations.

• Percentage of travel 10%
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15…