Quality Engineer

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Job Title:  Quality Engineer Location:  Hybrid in Eagan, MN Employment Type:  Contract to Hire
About the Role: Our client is seeking a detail-oriented and proactive Quality Engineer to join our team. This role supports cross-functional departments including Quality, Regulatory, Engineering, Manufacturing, Sales, Marketing, Accounting, and Customer Service. The Quality Engineer will be responsible for managing complaints, CAPAs, document control, calibration systems, audits, technical files, supplier performance, and other quality and regulatory functions. Key Responsibilities: Ensure compliance with all applicable regulations, standards, procedures, and work instructions as defined in the Quality System Manual Manage the complaint handling system: document, review, investigate, and close complaints Investigate and document Corrective and Preventive Actions (CAPAs) Create and update procedures, work instructions, forms, and labels using Microsoft Office tools Maintain and manage the calibration system Review and release sterile products Support cleanroom environmental monitoring activities Participate in supplier performance management and sourcing initiatives Review and approve document changes Compile and maintain technical documentation including clinical evaluation reports, usability engineering reports, risk management files, and validation records Conduct internal, supplier, and design history file audits Assist Documentation Coordinator and Quality Inspector with document changes, training, inspections, and non-conformance reports Assign and review deviations Support regulatory agency listings and annual registrations Assist with inspections and audits by FDA, Notified Bodies, OSHA, and other regulatory agencies Lead or support customer audits Compile Design History Files Maintain the Approved Supplier List and support sourcing projects Perform other duties as assigned Qualifications:
Bachelor’s degree in Engineering preferred; 0–2 years of experience in manufacturing Without a degree: minimum 3 years of experience in the medical device industry with demonstrated technical aptitude Proficiency in Microsoft Office Suite, Adobe Acrobat, and Visio Familiarity with FDA 21 CFR Regulations, ISO 13485, ISO 14971, Health Canada, and EU MDR Strong verbal and written communication skills in English Excellent attention to detail and organizational skills Preferred Qualifications: Experience with drafting standards and CAD software (SolidWorks, AutoCAD) Familiarity with eQMS, labeling software, and ERP systems Basic analytical and problem-solving skills Certified Quality Engineer (CQE) or equivalent training
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Location:
Eagan

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