Elucent Medical Inc.
Supplier Quality Engineer II
Elucent Medical Inc., Eden Prairie, Minnesota, United States, 55344
Overview
Supplier Quality Engineer II at Elucent Medical Inc. This role leads the resolution of supplier quality issues to ensure consistent component and material performance. It involves collaboration with suppliers, manufacturing, development, and supply chain teams to investigate nonconformances, implement corrective actions, and drive continuous improvement. The position supports supplier assessments, compliant documentation, and adherence to FDA 21 CFR Part 820 and ISO 13485 standards. Base pay range
$95,000.00/yr - $105,000.00/yr Details
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
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. Qualifications
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. Leadership / Required Skills/Abilities: 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 and issues, ensuring regulatory and internal procedure compliance. Collaborates on cross-functional teams to define and implement robust supplier quality assurance strategies aligned with quality system requirements and product safety. Communication : Excellent written and oral communication skills; ability to respond to inquiries from suppliers, customers, and regulatory agencies; ability to review, analyze, summarize, interpret data; write reports; and give presentations. Physical Requirements / Work Conditions : 10% travel; prolonged sitting at a desk and computer work; ability to lift up to 15 pounds; Office and Manufacturing floor. Benefits, Culture and Work Environment
Elucent Medical provides comprehensive benefits including health insurance, retirement savings with company matching, flexible work arrangements, paid time off, and ongoing professional development opportunities. Full-time Employees Are Provided 401(k); 401(k) matching (4%); Dental, Health, Vision insurance; Paid Holidays, Paid Vacation, Paid Sick Days; Short Term Disability; Long Term Disability; Life Insurance; Pet Insurance; Employee Assistance Programs. Equal Employment Opportunity
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 required of the employee. Duties, responsibilities and activities may change at any time with or without notice. Job Function and Industry
Job function: Quality Assurance Industries: Medical Equipment Manufacturing
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Supplier Quality Engineer II at Elucent Medical Inc. This role leads the resolution of supplier quality issues to ensure consistent component and material performance. It involves collaboration with suppliers, manufacturing, development, and supply chain teams to investigate nonconformances, implement corrective actions, and drive continuous improvement. The position supports supplier assessments, compliant documentation, and adherence to FDA 21 CFR Part 820 and ISO 13485 standards. Base pay range
$95,000.00/yr - $105,000.00/yr Details
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
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. Qualifications
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. Leadership / Required Skills/Abilities: 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 and issues, ensuring regulatory and internal procedure compliance. Collaborates on cross-functional teams to define and implement robust supplier quality assurance strategies aligned with quality system requirements and product safety. Communication : Excellent written and oral communication skills; ability to respond to inquiries from suppliers, customers, and regulatory agencies; ability to review, analyze, summarize, interpret data; write reports; and give presentations. Physical Requirements / Work Conditions : 10% travel; prolonged sitting at a desk and computer work; ability to lift up to 15 pounds; Office and Manufacturing floor. Benefits, Culture and Work Environment
Elucent Medical provides comprehensive benefits including health insurance, retirement savings with company matching, flexible work arrangements, paid time off, and ongoing professional development opportunities. Full-time Employees Are Provided 401(k); 401(k) matching (4%); Dental, Health, Vision insurance; Paid Holidays, Paid Vacation, Paid Sick Days; Short Term Disability; Long Term Disability; Life Insurance; Pet Insurance; Employee Assistance Programs. Equal Employment Opportunity
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 required of the employee. Duties, responsibilities and activities may change at any time with or without notice. Job Function and Industry
Job function: Quality Assurance Industries: Medical Equipment Manufacturing
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