Happiest Baby SNOO, the safest and smartest baby bed and 5-second swaddle, 5 S's and baby sleep advice, and toddler tips brought to you by Dr. Harvey Karp. Backed by GV and Lux.
About the role
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.
What they're looking for
- 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
More about this role
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...
Browse similar: Startup jobs · Remote jobs