POSITION TITLE: Quality & QMS System Specialist/Manager
BUSINESS UNIT: Quality and Regulatory Department
LOCATION: Lehi, Utah (Hybrid) or Remote
SUMMARY:
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. With the recent launch of our BabySat and Dream Sock, as medical devices, Owlet needs talented quality/regulatory expertise to join our Quality and Regulatory team to continue to support and evolve our Quality Management System (QMS).
We are seeking a highly skilled and experienced Quality & QMS System Specialist/Manager who is very hands on and is eager to touch all aspects of quality and compliance throughout the lifecycle of both our consumer and medical products here at Owlet. This person should be highly knowledgeable and experienced in medical product regulations, quality audits, quality policies and procedures, QMS systems, and implementing these systems within medical device or life sciences companies.
We are planning to fill this role as a Quality Specialist II (Individual Contributor II) or a Quality Systems Manager (Manager Level), depending on the experience and qualifications of the candidate.
PRIMARY RESPONSIBILITIES:
As a Quality & QMS System Specialist/Manager, you will be responsible for and/or have experience in, the following:
QMS System Management
- Ensure Owlet’s QMS adheres to ISO 13485 standards and any other relevant regulatory requirements including MDSAP, EU and UK MDR
- Continually monitor and evaluate QMS processes to identify areas for improvement
- Integrate current QMS process into the newly implemented eQMS system for greater efficiency and resource management
- Own integrity of data, processes, and permissions within the QMS system
- Education and training Owlet employees on the QMS systems and quality/regulatory aspects of Owlet’s business
- Review, prepare and approve QMS documentation within Owlet’s eQMS systems, including but not limited to Arena
Quality & Compliance for Medical Device/Life Sciences
- Review and approve CAPAs, providing risk management input and assessments
- Develop, maintain, and manage Owlet’s quality and regulatory policies, SOPs, and associated processes and procedures.
- Stay abreast of changes to standards and regulations and implement necessary adjustments to processes or procedures in order to maintain compliance
- Prepare for and facilitate internal/external audit activities (FDA, ISO, MDSAP, etc.), and ensure timely resolution of audit findings and CAPAs.
- Conduct/Update both internal/external risk assessments and track all findings
- Supports completion and execution of Engineering Change Orders (ECOs) and Product/Process Change Orders (MOCs)
- Work closely with cross-functional teams, including Engineering, Product, Regulatory Affairs, Legal, Medical Affairs and Program Management, to ensure alignment and integration of quality processes throughout the product life cycle.
- Experience with FDA-class II or above medical products, drugs, digital health or life sciences products relevant and transferable to Owlet’s business
Team Management (Manager Level)
- Oversee, train or enable quality specialists or other team members to ensure QMS system and compliance requirements are being met across Owlet
SKILLS AND QUALIFICATIONS:
- At least 3 years’ of relevant work experience
- Bachelor’s Degree in a scientific discipline preferred, but not required
- Experience/Training in ISO:13485, GMPs, or other medical products standards
- QMS Software experience
- Outstanding communication skills
- Problem solving and continuous improvement mindset
- Excellent organization and a keen eye for detail
- Unquestioned integrity and values that the organization can trust without reservation
- Must be flexible with the ability to change, adapt, and grow
- Adept with Google Suite and Microsoft Office Products: Particularly Word/Docs and Excel/Sheets
- Technical writing skills a plus
Owlet Baby Care, Inc. is an 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.