Senior Quality Engineer

Responsibilities

• Provide quality engineering leadership for manufacturing, assembly, testing, packaging, and labeling operations
• Ensure compliance with FDA QSR (21 CFR 820), ISO 13485, and other regulatory requirements
• Lead document change requests, impact assessments, and nonconformance investigations
• Drive root cause analysis, disposition decisions, and CAPA activities
• Apply statistical methods and structured problem-solving to drive continuous improvement
• Maintain risk management and DMR documentation for commercial products
• Review and approve process and test method validations

Requirements

• 5+ years of experience as a Quality Engineer in the medical device industry
• Bachelor's degree in Engineering (Mechanical, Material Science, or Biomedical) or a related Science
• Strong working knowledge of 21 CFR 820, ISO 13485, and ISO 14971
• Demonstrated skills in statistical analysis and problem-solving
• Experience participating in audits

Preferred Qualifications

• Certified Quality Engineer (CQE)
• Certified Quality Auditor (CQA)
• Six Sigma Belt

About the Company

Tactile Medical specializes in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency, and respiratory illnesses.