CAPA Specialist - Medical Devices (Contract)

Happiest Baby, Inc.; Los Angeles (CA); Hybrid; USD 100,000 - 150,000; 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 stepping into an active CAPA backlog and driving investigations to well-documented closure, in line with FDA and ISO requirements.

The ideal candidate has 5+ years in medical device quality, experience leading CAPA investigations, and familiarity with design controls. Remote or hybrid/onsite in Los Angeles options provide flexibility while ensuring effective

Qualifications

• Bachelor's degree in engineering, life sciences, quality or related technical discipline; or equivalent experience.
• 5+ years in quality assurance, quality engineering, or quality systems in the medical device industry, including hands-on CAPA investigations.
• Proven success leading complex investigations, root-cause analysis, risk-based action plans, and confirming effectiveness.
• Working knowledge of FDA 21 CFR 820 (QMSR), ISO 13485:2016, and ISO 14971; familiarity with complaint-handling and medical device reporting concepts.
• Experience with design controls (21 CFR 820.30) and design history file documentation is helpful.

Responsibilities

• Execute CAPA records from initiation to closure following FDA and ISO guidelines.
• Triage backlog, baseline problem statements, and drive overdue CAPAs to closure.
• Support cross-functional investigations across product, process, supplier, and nonconformance issues with thorough evidence.
• Apply structured root-cause methods such as 5-Why, Ishikawa, fault-tree, 8D, DMAIC and relevant statistics.
• Ensure actions address root causes without adding new risk per ISO 14971.
• Track deliverables, due dates, and escalation needs across CAPAs.
• Review CAPA records for quality, completeness, traceability, and readiness for regulatory review.
• Prepare CAPA status, aging, recurrence, effectiveness, and trend data for management reviews.
• Feed CAPA outputs into risk management, post-market surveillance, and regulatory reporting as applicable.
• Support remediation of design documentation gaps and coordinate closure with design engineering.

Skills

CAPA investigations

Root-cause analysis

Risk management

Quality systems

FDA 21 CFR 820

ISO 13485

ISO 14971

Design controls familiarity

Education

Bachelor’s degree in engineering, life sciences, quality

Job description

Happiest Baby, Inc. seeks a CAPA Specialist for a contract engagement to strengthen our quality system. This hands-on role requires stepping into an active CAPA backlog and driving investigations to well-documented closure, in line with FDA and ISO requirements.

The ideal candidate has 5+ years in medical device quality, experience leading CAPA investigations, and familiarity with design controls. Remote or hybrid/onsite in Los Angeles options provide flexibility while ensuring effective