CAPA Engineer

Virtue America; Utah; On-site; USD 90,000 - 130,000; Full time

Job summary

Virtue America is seeking an experienced CAPA Engineer to support CAPA processes, quality compliance, and continuous improvement within the medical device industry. The role emphasizes guiding CAPA personnel, supporting the CAPA Chair and review activities, owning multiple CAPAs through closure, and driving timely resolutions while ensuring documentation and regulatory compliance across quality systems.

You will collaborate with cross-functional teams, analyze root causes, implement corrective

Qualifications

• 7+ years of medical device quality experience.
• Strong experience at the Quality Engineer level.
• Hands-on experience with CAPA, RCA, and NCRs.
• Experience with interventional medical devices and delivery systems manufacturing.
• Proven CAPA ownership and coaching others on CAPA processes.
• Strong knowledge of Medical Device Quality Systems, Quality & Regulatory requirements.
• Excellent written, verbal, interpersonal, and technical writing skills.

Responsibilities

• Provide guidance and coaching to CAPA personnel
• Support the CAPA Chair and CAPA review activities
• Own and manage multiple CAPAs through closure
• Drive CAPA process acceleration and timely resolution
• Support Quality System updates and modifications
• Ensure documentation and regulatory compliance

Skills

CAPA ownership

RCA

NCRs

Medical device quality systems

CAPA coaching

Regulatory compliance

Job description

We are seeking an experienced CAPA Engineer to support CAPA processes, quality compliance, and continuous improvement within the medical device industry.

Key Responsibilities

• Provide guidance and coaching to CAPA personnel
• Support the CAPA Chair and CAPA review activities
• Own and manage multiple CAPAs through closure
• Drive CAPA process acceleration and timely resolution
• Support Quality System updates and modifications
• Ensure documentation and regulatory compliance

Required Qualifications

• 7+ years of medical device quality experience
• Strong experience at the Quality Engineer level
• Hands-on experience with CAPA, Root Cause Analysis (RCA), and NCRs
• Experience with interventional medical devices and delivery systems manufacturing
• Proven CAPA ownership and experience coaching others on CAPA processes
• Strong knowledge of Medical Device Quality Systems, Quality & Regulatory requirements
• Excellent written, verbal, interpersonal, and technical writing skills