Senior Quality Engineer.

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. The Senior Quality Engineer provides quality engineering leadership for manufacturing and post‐market activities supporting commercial medical devices. This role partners closely with Operations, Engineering, and Supply Chain to ensure regulatory compliance, effective risk management, and sustained product and process performance throughout the product lifecycle. Responsibilities focus on non‐design quality activities, including change management, nonconformance, CAPA, complaint investigations, and continuous improvement within a regulated environment.

Responsibilities:

• 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
• Apply structured problem‐solving and statistical methods (e.g., 5 Whys, Fishbone, fault tree analysis, SPC) to drive data‐based decisions and continuous improvement
• 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
• Other duties as assigned

Qualifications

Required:

• 5+ years of experience as a Quality Engineer within the medical device industry
• Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science

Preferred:

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

Knowledge & Skills

• Strong working knowledge of 21 CFR 820, ISO 13485, ISO 14971
• Demonstrated skills in statistical analysis
• Strong analytical and problem-solving skills
• Ability to work in a fast paced, dynamic and growth environment
• Excellent interpersonal skills: ability to articulate verbally and written, review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and lead or conduct teams and meetings
• Proven ability to work with minimal direction, as well as be resourceful and independent in solving problems and multi-task effectively
• Strong attention to detail
• Ability to educate cross-functional peers, stakeholders, suppliers and management on quality requirements
• Experienced with participation in audits