CAPA Specialist (Product and Process)

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.