CAPA Specialist (Product and Process)

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

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.