Remote CAPA Lead – Medical Device Quality Investigator

Happiest-Baby,-Inc; Los Angeles (CA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Happiest Baby, Inc. seeks a CAPA Specialist for a contract engagement to strengthen our quality system. This hands-on role requires leading CAPA investigations, remediation backlogs, and ensuring compliant closure under FDA 21 CFR 820 and ISO 13485.

The candidate will work remote or hybrid/onsite in Los Angeles, collaborating across functions and delivering well-documented records and action plans that improve product safety.

Qualifications

• 5+ years in quality assurance or quality systems in medical devices with hands-on CAPA leadership.
• Demonstrated success leading complex investigations and risk-based action plans.
• Familiarity with FDA 21 CFR 820, ISO 13485:2016, and ISO 14971 concepts.

Responsibilities

• Execute CAPA records from initiation through closure per FDA and ISO standards.
• Triage backlog and drive overdue CAPAs to timely closure.
• Support cross-functional investigations across product, process, supplier, and nonconformance issues.

Skills

CAPA investigations

Root-cause analysis

Risk-based action plans

Regulatory knowledge

Quality systems

Education

Bachelor's degree in engineering, life sciences, quality, or related

Tools

QMS / electronic quality system

Job description

Happiest Baby, Inc. seeks a CAPA Specialist for a contract engagement to strengthen our quality system. This hands-on role requires leading CAPA investigations, remediation backlogs, and ensuring compliant closure under FDA 21 CFR 820 and ISO 13485.

The candidate will work remote or hybrid/onsite in Los Angeles, collaborating across functions and delivering well-documented records and action plans that improve product safety.