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Lead Quality Assurance Engineer
2 months ago
Company Overview
Happiest Baby, Inc. is dedicated to supporting parents in nurturing healthy and joyful children. We have developed SNOO, an innovative and secure baby bed, and are continuously working on groundbreaking products, resources, and services.
SNOO enhances sleep duration by 1-2 hours nightly and ensures infants are positioned safely for rest, adhering to the back-sleeping guideline, which significantly lowers the risk of Sudden Infant Death Syndrome (SIDS). With FDA De Novo Approval for its safety features, SNOO has garnered numerous prestigious awards, aided countless families, and is utilized in over 100 healthcare facilities, while also being featured in several esteemed museums, including the Smithsonian Institution.
Founded by renowned pediatrician Dr. Harvey Karp and entrepreneur Nina Montée-Karp, Happiest Baby benefits from Dr. Karp's extensive experience and acclaimed publications, which have reached millions of parents worldwide.
Key Responsibilities
- Quality Assurance Initiatives
- Oversee production and refurbishment processes by implementing quality standards, conducting first article inspections, and preparing for audits. Lead risk assessment activities and FMEAs, ensuring quality is integrated into manufacturing and refurbishment workflows.
- Direct teams in the issuance of ECOs and CAPAs, as well as in investigating customer complaints.
- Apply statistical methods and data analysis to uncover trends and root causes of quality concerns, fostering proactive quality enhancements and risk management strategies.
- Evaluate and enhance supplier quality metrics.
- Establish Critical-to-Quality performance indicators to assess and elevate product quality.
- Champion continuous improvement initiatives based on Root Cause Analysis (RCA) and identified opportunities.
- Act as an Internal Auditor to uphold the quality internal audit framework.
- New Product Development
- Manage NPI builds and quality phase-gate deliverables throughout the product lifecycle, from concept to production readiness.
- Engage in design reviews and oversee all facets of the Design Control process for new products, guiding Design Control and Change Control efforts.
- Formulate and implement quality plans for all product lines.
- Regulatory Compliance
- Ensure adherence to established internal protocols and FDA Quality System Requirements, including 60601 and MDR.
- Assist with regulatory body engagements to validate quality system compliance.
- Support certification and recertification processes for various markets.
- Provide mentorship and support to peers and quality team members on industry best practices.
Qualifications
- Minimum Requirements:
- Bachelor's or Master's degree in Engineering or a related discipline, with over 7 years of experience in medical or consumer electronics.
- Expertise in interpreting and ensuring compliance with regulatory and safety standards, as well as quality management system (QMS) requirements.
- Experience in data-driven root cause analysis and continuous improvement methodologies.
- Strong grasp of engineering principles, design analysis, and manufacturing processes.
- Ability to interpret mechanical drawings and specifications.
- Excellent communication skills and capacity to prioritize tasks based on organizational needs.
- Proficiency in Microsoft Office Suite and collaboration tools.
- Willingness to travel as necessary.
- Preferred Qualifications:
- ASQ Certification as a Certified Quality Engineer (CQE) and Six Sigma Green Belt.
- Experience in conducting Supplier Quality Systems Audits and monitoring supplier performance.
- Demonstrated leadership in cross-functional teams and strong project management capabilities.
- Familiarity with quality tools such as 8D, SPC, FMEA, and PPAP.
- Ability to analyze extensive data sets and make informed decisions.
- Knowledge of document control systems.
- Experience with testing complete IoT products, including firmware and software.
Benefits
- Comprehensive health, dental, and vision plans.
- Flexible vacation policy.
- 401(k) retirement plan.
- Daily catered lunches.
- Collaborate with a dedicated team focused on making a difference in the lives of families.
Salary range: $85,000 - $130,000
