This position has the responsibility and authority to develop, maintain and certify Owlet’s ISO 13584 Quality System. In addition, this role will lead internal audits, customer audits, ISO Registration audits, and FDA Inspections.
- Be the Champion and subject matter expert for Owlet’s ISO 13485 compliant Quality System
- Ensure Owlet’s quality system development, effective maintenance and continued compliance with medical device regulations and standards (i.e., 21 CFR part 820, ISO 13485)
- Lead department activities within the Quality Systems function (i.e., Document and Data Control, Retain and Records Retention, Training, Corrective and Preventive Action, Change Control, Deviation, Supplier Audits, Supplier Corrective Action Requests, Electronic System Development/Validation, Management Review, Risk Management, Auditing, Agency Inspections and Quality Improvement Initiatives)
- Ensure the accuracy of the regulatory contact and submission log is maintained; provide regulatory guidance to various internal project teams as necessary.
- Continue to develop and enhance current regulatory knowledge to support surveillance activities.
- Lead the support of currently marketed products including review of engineering changes, labeling, promotional material, product chances and documentation of changes requiring government approval.
- Responsible for proposing and execution of Quality System improvement opportunities, and continued certifications
- Responsible for writing, reviewing and approving validations in accordance with regulatory requirements.
- Establish, maintain and report Quality System metrics to management
- Support the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.
- Other duties as assigned
Required Skills and Qualifications:
- Bachelor’s degree required (Quality, Regulatory, Engineering, Business or Life Sciences) with 6+ years of experience, Master’s degree preferred
- American Society of Quality, Certified Quality Auditor (CQA) credentials, is required
- Knowledge of the U.S. and international medical device quality system regulations, standards and best practices (21 CFR 820, ISO 13485)
- Experience with compliance assessments, gap assessments and risk management assessments.
- Experience with program change management practices, lean or six sigma, program and system integration efforts
- Strong computer skills; Word, Excel, PowerPoint
- Strong interpersonal skills are required. Must be an effective team player intra-departmentally and cross-functionally.
- Regulatory Affairs Professional Society (RAPS) Certification preferred
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.