Quality Engineer, Medical Devices — CAPA & Post-Market Lead

Creative Solutions Services, LLC; Cheyenne (WY); On-site; USD 110,000 - 160,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Quality Engineering leader to develop and maintain quality methodologies for medical devices, supporting new product development and manufacturing operations.

This role mentors teams, drives CAPA and process control improvements, and coordinates with contract manufacturers and internal quality/design groups to ensure compliance and robust post-market surveillance.

Qualifications

• 5+ years of experience with a BS degree.
• Medical device experience.
• Ability to take direction and work independently.
• Experience owning CAPA.
• Root cause analysis experience.

Responsibilities

• Provide leadership on cross-functional engineering initiatives.
• Mentor engineering teams and coach project direction.
• Identify and implement quality engineering practices.
• Oversee CAPA and process controls for manufacturing.
• Coordinate with contract manufacturers and internal teams.
• Author post-market surveillance reports and support design changes.

Skills

Leadership

Quality engineering

CAPA

Root cause analysis

Mentoring

Education

BS

MS

Job description

Creative Solutions Services, LLC seeks a Quality Engineering leader to develop and maintain quality methodologies for medical devices, supporting new product development and manufacturing operations.

This role mentors teams, drives CAPA and process control improvements, and coordinates with contract manufacturers and internal quality/design groups to ensure compliance and robust post-market surveillance.