Director of Design Quality Engineering-Oral Healthcare
Location
Bothell, WA
Level
VP / Executive
Department
MedTech
Type
Salary
$172,000 - $275,000
Job Description
Posted on:
2025-11-25
Responsibilities
- Develop and execute product verification and validation strategies.
- Lead the design lifecycle from concept to transfer, ensuring compliance.
- Promote advanced Quality Engineering practices for continuous improvement.
- Integrate post-market surveillance data into lifecycle processes.
- Oversee design evaluations and resolve quality issues.
- Direct audit readiness and responses to inspections.
- Lead initiatives in risk management and talent development.
Job Requirements
- Minimum of 10+ years in Product Design Quality/Control.
- Experience with ISO 13485 and ISO 9001 standards.
- Expertise in Design Quality/Controls and Risk Management.
- Experience in hardware and software development lifecycles.
- Proven ability to lead quality improvement initiatives.
- Extensive knowledge in Design Verification/Validation and auditing.
- Bachelor’s degree in Quality, Engineering, or Scientific discipline; certifications desired.
