Quality Engineer III: Medical Devices, CAPA & Quality Systems

TALENT Software Services; Maple Grove (MN); On-site; USD 100,000 - 140,000; Full time

Job summary

TALENT Software Services seeks a senior Quality Engineer to develop and maintain quality engineering methodologies that meet regulatory requirements and customer expectations. The role focuses on CAPA, post-market surveillance, and design/ supplier quality within medical devices.

Responsibilities include leading cross-functional quality initiatives, mentoring engineers, and implementing robust process controls to ensure compliant, high-quality products across development and manufacturing stages.

Qualifications

• 5+ years with a BS degree; 3–4 years with an MS degree.
• Medical device experience required.
• Experience owning CAPA and post-market surveillance activities preferred.
• Ability to take direction and work independently.

Responsibilities

• Provides leadership in engineering initiatives across departments.
• Coaches and mentors engineering personnel.
• Identifies and implements best-in-class Quality Engineering practices.
• Supports design changes and supplier quality activities; CAPA ownership.
• Ensures quality systems, processes, and CAPA align with internal and external requirements.

Skills

CAPA ownership

Root cause analysis

Quality systems

Leadership

Education

BS in Biomedical/Mechanical Eng

MS in Biomedical/Quality Eng

Job description

TALENT Software Services seeks a senior Quality Engineer to develop and maintain quality engineering methodologies that meet regulatory requirements and customer expectations. The role focuses on CAPA, post-market surveillance, and design/ supplier quality within medical devices.

Responsibilities include leading cross-functional quality initiatives, mentoring engineers, and implementing robust process controls to ensure compliant, high-quality products across development and manufacturing stages.