Senior Quality Engineer

Tactile Medical; Minneapolis (MN); On-site; USD 93,600 - 131,040; Full time

Benefits offered by this job

Medical, dental and vision benefits

Retirement benefits

Employee stock purchase plan

Paid time off

Parental leave

Life insurance

Disability coverage

Job summary

Tactile Medical in Minneapolis is seeking a Senior Quality Engineer to oversee quality engineering leadership for manufacturing processes of medical devices. You will ensure compliance with FDA regulations and ISO standards while collaborating with cross-functional teams. The ideal candidate has over 5 years of experience in quality engineering and a relevant Bachelor's degree.

This role offers a competitive salary range between $93,600 and $131,040, complemented by a comprehensive benefits package including medical and dental coverage, retirement benefits, and paid time off.

Qualifications

• 5+ years of experience as a Quality Engineer within the medical device industry.
• Strong working knowledge of regulatory standards relevant to the role.

Responsibilities

• Provide leadership for quality engineering in manufacturing and assembly operations.
• Ensure compliance with FDA and ISO standards.
• Lead nonconformance investigations and CAPA activities.
• Apply statistical methods for continuous improvement.

Skills

Statistical analysis

Analytical skills

Problem-solving

Knowledge of 21 CFR 820

Knowledge of ISO 13485

Interpersonal skills

Education

Bachelor's degree in Engineering or related Science

Job description

At Tactile Medical, we specialise 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)

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

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 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.

US Pay Range

$93,600 - $131,040 USD

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