Quality Specialist I / II

Owlet is changing the world of parenting with meaningful products that truly make a difference for millions around the world by bringing joy, peace and sleep to the parenting journey. Owlet has helped more than a million parents keep their children safe. We are focused on helping parents take care of their little ones so we can keep every baby safe and healthy.

Job Overview :

Quality Specialist I / II is a customer service role dedicated to managing health and safety-related product complaints. Responsibilities include direct communication with customers via phone and email, detailed complaint intake, investigating complaint data, coordinating with cross-functional teams, and ensuring accurate documentation. The specialist also evaluates complaints for regulatory reportability in compliance with global requirements. This position combines customer service skills and technical expertise to promote patient safety and regulatory compliance. This role will also include quality systems tasks such as CAPA participation, internal auditing, and other QMS project tasks as assigned.

Key Responsibilities

• Serve as the primary contact for customers reporting health and safety–related complaints, providing professional, empathetic, and solution-oriented communication.
• Handle complaint intake through phone and email, collecting detailed and accurate information.
• Document all complaints promptly and accurately in the electronic QMS.
• Investigate complaint data, including reviewing device logs, usage patterns, and customer-reported details to identify root causes or contributing factors.
• Collaborate with engineering, clinical, and other teams to assess and resolve product issues.
• Evaluate complaints for reportability under FDA MDR and other global regulatory requirements.
• Prepare clear, objective summaries and regulatory justifications for complaint investigations.
• Monitor complaint timelines to ensure timely evaluation, reporting, and closure.
• Identify complaint trends and escalate potential safety issues.
• Support audits and inspections by providing complaint, investigation, and reportability documentation.
• Recommend improvements to complaint handling processes and customer experience.
• Participate in CAPA’s related to complaint investigation.
• Participate in internal audits and other QMS project activities as assigned.

Requirements

Qualifications

Great to have :

Benefits

Owlet offers a comprehensive benefits package that supports your health, financial well-being, and work-life balance :

Owlet Baby Care, Inc. is the equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.