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
Requirements
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
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
To learn more about our Privacy Statement follow this link - https://tactilemedical.com/privacy-statement/
To learn more about our California Privacy Notice follow this link - https://tactilemedical.com/california-privacy-notice/
At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.
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.
Tactilemedical · Minneapolis, MN