Quality & QMS System Specialist I / II

POSITION TITLE: Quality & QMS System Specialist I / II

BUSINESS UNIT: Quality and Regulatory Department

LOCATION: U.S. 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 I or II 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 knowledgeable and experienced in medical product/life science regulated QMS.
We are planning to fill this role as a Quality Specialist I or II depending on experience.
PRIMARY RESPONSIBILITIES:
As a Quality & QMS System Specialist I or II, you will be responsible for and/or have experience in, the following:
Document and Change Control
Ensures all administrative documentation requirements are met for supported Quality Documentation, inclusive of document processing and records management.
● Facilitates the creation/revision, administration, review, of new and revised Quality Documentation within the Document Management System eQMS
● Assist with oversight of the document change management, including document uploads, impact assessment, approval management and change governance.
● Prepare, process and track and change control request documentation throughout its lifecycle to ensure tasks are completed in a timely manner.
● Performs final review of change requests and its documentation to ensure completeness, including documented evidence of impact assessments as a part of risk/regulatory management and completion of all actions required by the change have occurred.
● Supports completion and execution of Engineering Change Orders and Document Change Orders
Complaint
● Assess complaints for reportability in accordance with a variety of regulatory body requirements, including but not limited to FDA, Health Canada, and EU MDR.
● Ensure timely documentation, evaluation, and escalation of complaints that meet reportable criteria.
● Initiate and oversee complaint investigations as needed, coordinating efforts with cross-functional teams such as engineering, manufacturing, and customer service.
● Document investigation findings and ensure clear and concise reporting in compliance with quality system requirements.
Internal Audit
● Conduct and document internal quality system audits
● Support initiation of CAPA, SCAR, etc. related to audits until the closure of audit findings.
● Communicate and coordinate audit activities with other departments.
Training Compliance:
● Oversee the implementation and maintenance of company-wide training programs, ensuring alignment with regulatory and internal quality requirements.
● Audit training records to verify completion, accuracy, and adherence to assigned schedules.
● Develop, assign, and update training materials in collaboration with subject matter experts to address identified gaps or regulatory changes.
● Monitor and report on training compliance metrics to management and relevant stakeholders.
SKILLS AND QUALIFICATIONS:
● At least 2 years’ of relevant QMS work experience
● Bachelor’s Degree in a scientific discipline preferred, but not required
● Experience/Training in ISO:13485, GMPs, or other medical products standards
● eQMS 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.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.