Quality Engineer

Senior Quality EngineerTactile Medical specializes 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 safetyEnsure ongoing compliance with FDA QSR (21 CFR 820), ISO 13485, and applicable regulatory and quality system requirementsServe as the Quality representative on operations and sustaining teams, partnering cross-functionally to balance compliance, risk, and business needsLead document change requests and impact assessments to ensure changes maintain product safety, performance, and regulatory complianceLead and support nonconformance investigations, root cause analysis, disposition decisions, and CAPA activities through effective closure and verification of effectivenessApply structured problem-solving and statistical methods (e.g., 5 Whys, Fishbone, fault tree analysis, SPC) to drive data-based decisions and continuous improvementOwn and maintain risk management and DMR documentation for commercial products, including periodic review of complaints, nonconformance trends, and post-market signalsReview and approve process and test method validations, manage quality metrics, and oversee incoming material quality and acceptance activitiesOther duties as assignedQualificationsRequired:5+ years of experience as a Quality Engineer within the medical device industryBachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related SciencePreferred:Certified Quality Engineer (CQE)Certified Quality Auditor (CQA)Six Sigma BeltKnowledge & SkillsStrong working knowledge of 21 CFR 820, ISO 13485, ISO 14971Demonstrated skills in statistical analysisStrong analytical and problem-solving skillsAbility to work in a fast paced, dynamic and growth environmentExcellent 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 meetingsProven ability to work with minimal direction, as well as be resourceful and independent in solving problems and multi-task effectivelyStrong attention to detailAbility to educate cross-functional peers, stakeholders, suppliers and management on quality requirementsExperienced with participation in auditsOur total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions. Below is the starting salary or hourly range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.US Pay Range $93,600 - $131,040 USD