<link id='css--app'rel="stylesheet" href="/dist/css/app.min.css"> Opportunities – Trilogy

Opportunities

Quality Engineer at Owlet Baby Care
Remote

Summary:

The Quality Specialist-Complaint Coordinator at Owlet is a hands-on role touching all aspects of quality and compliance throughout the lifecycle of a product with special attention to proper handling of incoming complaints.

 

Primary Responsibilities:

  • Ensure proper handling, documentation, and reporting of any adverse issues for medical and consumer products in accordance with 21 CFR 820, ISO 13485, ISO9001, and European Medical Device Vigilance Requirements
  • Records and provides regulatory reportability decisions on complaints
  • Coordinates with internal departments (Customer Service, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing and R&D) to incorporate vital input into medical device event reports
  • Serve as a project manager for Owlet’s quality and regulatory team managing timelines and deliverables for complaint investigations and OKRs (Objectives and Key Results)
  • Establish and review supplier quality agreements
  • Performs root cause investigations and is involved in CAPA (Corrective and Preventive Action) activities
  • Assist in the development of quality management procedures
  • Work with design and engineering teams on executing Owlet’s change management process
  • Assist with routine quality audits of suppliers
  • Assist and support all document control functions
  • Other special projects under the direction of QMS and Compliance Manager

 

Required Skills and Qualifications:

  • Associates Degree with 3 years of experience or Bachelors degree with 1 year experience
  • ISO13485 Internal Auditor Certification preferred
  • Technical writing skills preferred
  • Experience with Complaint Reporting and QMS software preferred
  • Adept with Microsoft Office products, particularly Excel and Word

Perks:

  • Flex time scheduling
  • Competitive compensation based on experience
  • Benefits package
  • Product discounts

 

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.