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The Role
Execute and remediate medical device CAPA records from containment and risk assessment through root-cause investigation, corrective action, effectiveness verification, and closure. Lead cross-functional investigations involving products, processes, suppliers, complaints, and nonconformances. Apply structured problem-solving methods, assess ISO 14971 risks, review CAPA documentation, prepare management reporting, and support design history file and design-control remediation.
Summary Generated by Built In
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
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.
- 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.
- 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.
Skills Required
- Bachelor's degree in engineering, life sciences, quality, or a related technical discipline, or equivalent education and experience.
- At least 5 years of experience in medical device quality assurance, quality engineering, or quality systems.
- Hands-on experience leading CAPA investigations.
- Experience leading complex investigations, facilitating root-cause analysis, developing 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 under 21 CFR 820.30 and design history file or design documentation structures.
- ASQ Certified Quality Engineer, Certified Quality Auditor, Six Sigma Green Belt, Six Sigma Black Belt, or comparable certification.
- Experience performing or remediating CAPA in an outsourced or contract-manufacturing model.
Happiest Baby Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Happiest Baby and has not been reviewed or approved by Happiest Baby.
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Fair & Transparent Compensation — Pay is considered competitive for several job families, with technical and leadership roles showing strong ranges that align to positive views of overall compensation. Overall compensation and benefits are viewed more favorably than some other work dimensions.
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Healthcare Strength — Medical, dental, and vision coverage are characterized as strong, with core plans complemented by life insurance and FSA/HSA options. Multiple comments highlight the quality of the health plans as a notable advantage.
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Parental & Family Support — Maternity and paternity leave receive positive emphasis alongside a family-friendly environment (e.g., a dedicated pumping room). New‑parent perks connected to the company’s products further reinforce direct support for families.
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The Company
What We Do
Happiest Baby is a mission-driven technology company dedicated to helping parents succeed at their most important job–raising healthy, happy children.
