Supplier Quality Engineer II

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 $105,000.00

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

About Elucent Medical:
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 are designed to transform traditional surgical instruments into "smart" tools, enhancing surgical precision and patient outcomes.

Job Summary:
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.

Supervisory Responsibilities:
None

Job Responsibilities:
Supplier Quality Experience

• 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.

Physical Requirements / Work Conditions:
Percentage of travel 10%
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
Office, Manufacturing floor

Elucent Medical Benefits, Culture and Work Environment
At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits, including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.

Full-time employees are provided:
401(k)
401(k) matching (4%)
Dental insurance
Health insurance
Vision insurance
Paid Holidays
Paid Vacation Days
Paid Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Pet Insurance
Employee Assistance Programs

Affirmative Action / EEO Statement
Elucent Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.