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Elucent Medical Inc. · 1 month ago

Supplier Quality Engineer II

Eden Prairie, MN

Full-time

Onsite

Mid Level

$95K/yr - $105K/yr

4+ years exp

Elucent Medical is a medical device company focused on developing surgical navigation technologies to improve patient outcomes. The Supplier Quality Engineer II leads the resolution of supplier quality issues, collaborates with various teams, and ensures compliance with regulatory standards.

Health CareMedicalOncology

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

Qualification

Supplier Quality ExperienceMedical Device Quality SystemsStatistical AnalysisLeadershipCommunicationTechnical DocumentationOrganizational SkillsTime ManagementHands-on ApproachCross-functional Collaboration

Required

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

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