CAPA & Quality Systems Engineer

Accede Solutions Inc (accedesolution.com); Englewood (CO); On-site; USD 80,000 - 100,000; Full time

Job summary

Accede Solutions Inc in Englewood, CO is seeking a Quality Engineer for a 12-month contract. The candidate will manage CAPA processes, ensure compliance with global quality standards, and collaborate cross-functionally to drive improvements.

Ideal applicants should have a B.S. in engineering, expertise in CAPA processes, and experience in regulated industries such as medical devices. Strong technical writing and analytical skills are essential for success in this role.

Qualifications

• Bachelor's degree program in engineering.
• 3-5 years of experience in Quality Engineering focused on CAPA.
• Knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971.

Responsibilities

• Review, remediate, and migrate legacy CAPA records.
• Manage assigned CAPAs through all phases.
• Perform gap assessments of CAPA records.
• Partner with various departments for CAPA execution.
• Support compliance to global CAPA procedures.
• Assist with training related to CAPA procedures.

Skills

Working knowledge of CAPA processes

Experience with electronic Quality Management Systems

Knowledge of applicable regulations and standards

Strong technical writing skills

Strong organizational skills

Analytical/problem-solving skills

Ability to work cross-functionally

Proficiency with Microsoft Office

Medical device experience

Education

B.S. in engineering or similar degree

3-5 years of experience in Quality Engineering

Certified Quality Engineer (CQE)

Job description

Accede Solutions Inc in Englewood, CO is seeking a Quality Engineer for a 12-month contract. The candidate will manage CAPA processes, ensure compliance with global quality standards, and collaborate cross-functionally to drive improvements.

Ideal applicants should have a B.S. in engineering, expertise in CAPA processes, and experience in regulated industries such as medical devices. Strong technical writing and analytical skills are essential for success in this role.