Hiring: Senior Quality Engineer Company: Tactile Medical Location: New Brighton, MN Job Posted Time: 2026-09-10 11:24:53 Target Skills & Keywords : Assembly, Change Management, Regulatory Compliance, Risk Management, Root Cause Analysis, Six Sigma About the job Experience: •5+ years of experience as a Quality Engineer within the medical device industry Required Skills: •Provide quality engineering leadership and support for manufacturing, assembly, testing, packaging, and labeling operations, ensuring product quality and patient/user safety •Ensure ongoing compliance with FDA QSR (21 CFR 820), ISO 13485, and applicable regulatory and quality system requirements •Serve as the Quality representative on operations and sustaining teams, partnering cross‐functionally to balance compliance, risk, and business needs •Lead document change requests and impact assessments to ensure changes maintain product safety, performance, and regulatory compliance •Lead and support nonconformance investigations, root cause analysis, disposition decisions, and CAPA activities through effective closure and verification of effectiveness •Own and maintain risk management and DMR documentation for commercial products, including periodic review of complaints, nonconformance trends, and post‐market signals •Review and approve process and test method validations, manage quality metrics, and oversee incoming material quality and acceptance activities •Strong working knowledge of 21 CFR 820, ISO 13485, ISO 14971 Qualifications: •Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science Compensation: •$93,600 - $131,040 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!