Quality Specialist I - II
Title: Quality Specialist I/II Location: Remote Remote US Type: Full-time Workplace: Fully remote Job Description: 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 • 2+ years of Quality Management System (QMS) experience in the Medical Device, Pharmaceutical, or Biotechnology industries. • 1+ years in a clinical, customer service, or complaint handling role within regulated healthcare or medical device environments. • Knowledge of medical device regulations (FDA 21 CFR 803/820, ISO 13485, EU MDR). • Proven ability to communicate clearly and compassionately with customers by phone and email. • Strong analytical skills for investigating clinical data and device information. • Excellent written communication and documentation skills. • Proficiency with Google Workspace (Docs, Sheets, Slides, Drive, Gmail, Calendar). • Experience with eQMS software. Great to have: • Bachelor’s degree in nursing, health sciences, biomedical engineering, or a related clinical field; or equivalent experience. • Internal Auditing Training to 13485:2016 and MDSAP Benefits Owlet offers a comprehensive benefits package that supports your health, financial well-being, and work-life balance: • Health & Wellness: Multiple medical plan options (PPO and High-Deductible with HSA), plus dental, vision, life, and disability coverage. Wellness resources include mental health support, EAP access, and fitness incentives. • Financial Benefits: A competitive 401(k) plan with company match, employee stock purchase program, and potential equity grants. • Work-Life Balance: Generous flexible PTO policy, including Flex Fridays, paid parental leave (up to 14 weeks), and remote/hybrid work options. 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. Apply tot his job