Contract CAPA Specialist — Medical Device Quality

happiestbaby; Los Angeles (CA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Happiest Baby seeks a CAPA Specialist for a contract engagement to strengthen our quality system as we grow domestically and internationally. The role is hands-on, enabling rapid remediation of a CAPA backlog and driving investigations to well-documented closure.

The position can be remote or hybrid/onsite in Los Angeles, with extension potential based on business needs and regulatory considerations.

Qualifications

• Bachelor's degree in engineering, life sciences, quality, or related discipline.
• 5+ years in QA/quality systems for medical devices with hands-on CAPA investigations.
• Working knowledge of FDA 21 CFR 820, ISO 13485:2016, and ISO 14971.
• Familiarity with design controls (21 CFR 820.30) is helpful.

Responsibilities

• Lead CAPA investigations end-to-end per FDA and ISO requirements.
• Triage backlog and drive CAPA closure on schedule.
• Support cross-functional investigations across product, process, supplier, and nonconformance issues.
• Apply structured root-cause methods and ensure effective verification of actions.

Skills

CAPA investigations

Root-cause analysis

Quality systems

FDA 21 CFR 820

Education

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

Job description

Happiest Baby seeks a CAPA Specialist for a contract engagement to strengthen our quality system as we grow domestically and internationally. The role is hands-on, enabling rapid remediation of a CAPA backlog and driving investigations to well-documented closure.

The position can be remote or hybrid/onsite in Los Angeles, with extension potential based on business needs and regulatory considerations.