Director, Design Quality Engineering-Oral Healthcare
Location
Bothell, WA
Level
Manager / Director
Department
MedTech
Type
Salary
$181,000 - $289,000
Job Description
Posted on:
2026-03-03
Responsibilities
- Develop and execute product validation strategies using advanced statistics.
- Lead the full design lifecycle, ensuring compliance with global regulations.
- Promote advanced Quality Engineering practices for continuous improvement.
- Integrate Post Market Surveillance data into product lifecycle processes.
- Oversee design evaluations and root cause analyses for quality issues.
- Direct audit readiness and responses to inspections.
- Lead risk management and talent development initiatives in quality systems.
Job Requirements
- Minimum 10+ years of experience in Product Design Quality/Control.
- Extensive knowledge of ISO 13485 and ISO 9001 standards.
- Proven leadership in strategic quality improvement initiatives.
- Experience in hardware and software development lifecycles.
- Strong background in Design Verification/Validation planning and testing.
- Ability to maintain relationships with stakeholders at all levels.
- Bachelor’s degree in Quality, Engineering, or a Scientific discipline required.
