CAPA Specialist (Product and Process)

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

About the Role

Happiest Baby, the company behind the award‑winning SNOO Smart Bassinet, seeks a CAPA Specialist for a contract engagement to strengthen our quality system as we grow domestically and internationally. This is a hands-on role for an experienced medical device quality professional who can step in quickly, work through an active CAPA remediation backlog, and drive investigations to well‑documented, effective closure. The engagement can be remote or hybrid/onsite in Los Angeles, with the possibility of extension based on business needs.

Why Happiest Baby?

We're in an emerging market with a product that genuinely changes families' lives. We move fast, value rigor, and want quality professionals who bring sound judgment and a bias for action in equal measure. This contract has a clear, meaningful scope: the work you do will directly shape the strength of our quality system and the safety of products used by families around the world.

Job Responsibilities

• Execute CAPA records from initiation, containment, and risk assessment through root-cause investigation, action implementation, effectiveness verification, and closure, in conformance with FDA 21 CFR 820 (QMSR) and ISO 13485:2016.
• Work through the current CAPA remediation backlog: triage open and aging CAPAs, re-baseline problem statements and scope, and drive overdue or stalled records to closure on a committed schedule.
• Support cross-functional investigations spanning product, process, contract-manufacturing, supplier, complaint, and nonconformance issues; ensure scope, containment, and risk are complete and evidence-based.
• Apply structured root-cause and problem-solving methods — 3-Legged 5-Why, fishbone/Ishikawa, fault-tree analysis, 8D, DMAIC, and applicable statistical techniques.
• Challenge assumptions and test objective evidence to confirm root causes are substantiated, that actions address those causes, and that actions introduce no new risk (per ISO 14971).
• Track deliverables, due dates, and escalation needs across assigned CAPAs; flag overdue, stalled, or high-risk records.
• Define and review effectiveness-verification plans with measurable acceptance criteria, appropriate monitoring periods, and sound sampling.
• Review CAPA records for technical quality, completeness, and traceability, and prepare them for management and regulatory review in the electronic quality system.
• Prepare CAPA status, aging, recurrence, effectiveness, and trend data for the Management/CAPA Review Board.
• Feed CAPA outputs into risk management, post-market surveillance, and regulatory reporting / MDR as applicable.
• Support remediation of design documentation gaps (e.g., design history file, design outputs, verification/validation records) identified through CAPA, complaint, or risk-management activities, coordinating closure with design engineering.

Qualifications

• Bachelor's degree in engineering, life sciences, quality, or a related technical discipline, or an equivalent combination of education and experience.
• 5+ years in quality assurance, quality engineering, or quality systems in the medical device industry, including direct hands-on responsibility for leading CAPA investigations.
• Demonstrated success leading complex investigations, facilitating root-cause analysis, building risk-based action plans, and verifying effectiveness.
• Working knowledge of FDA 21 CFR 820 (QMSR), ISO 13485:2016, and ISO 14971; familiarity with complaint-handling and medical device reporting concepts.
• Working familiarity with design controls (21 CFR 820.30) and design history file / design documentation structure is helpful given the scope of current remediation work.

Preferred qualifications

• ASQ Certified Quality Engineer, Certified Quality Auditor, or Six Sigma Green/Black Belt, or comparable certification.
• Experience performing or remediating CAPA in an outsourced / contract-manufacturing model.