Head of Safety, Quality & Regulatory- Oral Health Care
Location
Bothell, WA
Level
VP / Executive
Department
MedTech
Type
Salary
$181,000 - $289,000
Job Description
Posted on:
2026-06-11
Responsibilities
- Lead the full design lifecycle from value proposition to end of life.
- Develop and execute product V&V and process validation strategies.
- Oversee design evaluations and root cause analyses for quality issues.
- Ensure timely execution of regulatory compliance activities.
- Direct audit readiness and responses to inspections.
- Promote advanced Quality Engineering practices for continuous improvement.
- Provide strategic direction and identify opportunities for quality improvement.
Job Requirements
- Minimum of 15+ years’ experience in Product Design Quality/Control/Regulatory Affairs.
- Extensive experience with ISO 13485 Medical Device/Technology and ISO 9001.
- Proven expertise in Design Quality/Controls and Risk Management-FMEA.
- Minimum Bachelor’s Degree in Quality, Engineering, or similar disciplines.
- Experience in strategic/functional team leadership and mentoring.
- Ability to meet physical, cognitive, and environmental job requirements.
- Must reside within commuting distance to Bothell, WA or be willing to relocate.
