Owlet is growing and on the search for an experienced Sr. Director of Quality Engineering and Regulatory Affairs to join our growing team. Our mission is to change the world by empowering parents with infant health tracking data. After two years of developing the world’s smallest baby specific pulse oximeter, Owlet launched online in 2016 and has seen tremendous growth, winning awards across the globe. However, our biggest accomplishment is giving thousands of parents peace of mind.
The Sr. Director of Quality Engineering and Regulatory Affairs is Owlet’s most senior quality and regulatory position and leads resources and efforts related to Quality Engineering and Risk Affairs across all Owlet products and markets.
- Lead Owlet’s Global Quality Engineering and Regulatory team, efforts, resources, systems, and processes to bring world class products to our customers.
- Lead the development, implementation, and management of Quality Management Systems (ISO 13485 and ISO 9001) consistent with company goals and policies.
- Serve as Management Representative during audits (FDA, ISO and other applicable audits) to ensure Quality System requirements are effectively established and maintained and report on the performance of the Quality System to the executive team.
- Ensure product quality meets or exceeds performance targets.
- Responsible for developing and maintaining relationships, as necessary with notified bodies, registrars, customers quality representatives and suppliers.
- Ultimately responsible for managing processes related to the handling of complaints, non-conformances, internal audits, and the CAPA system.
- Lead the drafting, reviewing and editing of material related to regulatory submissions, such as FDA Pre-Market Approval, Q-sub documentation and other regulatory submissions as needed.
- Responsible for regulatory submissions including IDEs, PMAs, 510(k)s, and their associated supplements and annual reports.
- Support new country registrations and manage re-registrations for commercial use.
- Ultimately responsible for RA review and approval of all marketing materials.
- Ultimately responsible in ensuring risk approach is adopted across product development cycle.
- Lead Owlet's quality engineering team to drive down product return rates and improve customer experience utilizing CS data, NPS feedback and returns analysis
- Drive, improve and report on Quality engineering department KPIs
- Be an effective agent of change and instill a culture of quality within the company
Required Skills and Qualifications:
- Bachelor’s Degree, preferably in Engineering
- 10+ years of relevant Quality Engineering and Regulatory experience
- In depth knowledge in implementing ISO 13485, ISO 14791, 21 CFR 820 and other applicable medical device standards in organizations
- 5+ years of experience in bringing Class II electronic medical devices to market
- General understanding of ICH, cGCP, cGMP, cGDP, FDA, ISO, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices.
- Minimum of 10 years of experience with FDA De Novo, 510(K), Medical Device Directive and other international country device registrations
- Strong leadership and interpersonal communication skills.
- Self-motivated with a proactive attitude and the ability to work independently.
Preferred Skills and Qualifications:
- Experience leading clinical research supporting medical device submissions
- Master’s degree in Engineering Management or Regulatory Science
- RAPS certification for Medical Devices
- ASQ certification – Quality Auditor, Quality Manager or Quality Engineer
Owlet employees participate in quarterly evaluations that include:
- Performance feedback
- Behavioral feedback
- Training and development opportunities
- Manager feedback
- Competitive compensation based on experience
- Flexible schedules
- Paid holidays
- Product discounts
- 401(k) program with company match
- Eligible for company-sponsored benefits package 1st day of the month, following your hire date
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.