Senior Quality Engineer, MedTech - Post-Market & CAPA Leader

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

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.