Tactile Medical
Senior Quality Engineer
Minneapolis, Minnesota · Senior
Sponsorship not specified$94k-$131kDetected 63 days ago
StatisticsComplianceSupply ChainMedical DevicesLeadershipProblem Solving
About the role
- The Senior Quality Engineer provides quality engineering leadership for manufacturing and post‐market activities supporting commercial medical devices.
- 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.
Responsibilities
- Provide quality engineering leadership and support for manufacturing, assembly, testing, packaging, and labeling operations, ensuring product quality and patient/user safety
- 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
- 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.
- focus on non‐design quality activities, including change management, nonconformance, CAPA, complaint investigations, and continuous improvement within a regulated environment.
Requirements
- Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Science
- Excellent interpersonal skills: ability to articulate verbally and written, review, analyze, summarize, and interpret data
Nice to have
- Certified Quality Engineer (CQE)
- Certified Quality Auditor (CQA)
- 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
Skills
- 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
- Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.
- US Pay Range
- $93,600 - $131,040 USD
- To learn more about our Privacy Statement follow this link - https://tactilemedical.com/privacy-statement/
Compensation
- Our 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 insu
Benefits
- 5+ years of experience as a Quality Engineer within the medical device industry
- At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses.
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This listing is sourced directly from Tactile Medical's careers page and normalized into a canonical job model.