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:
2025-11-04
Responsibilities
- Direct the End-to-End design control process and quality engineering practices.
- Develop and execute product verification and validation strategies.
- Lead the full design lifecycle ensuring regulatory compliance.
- Integrate post-market surveillance data to improve product quality.
- Oversee design evaluations and root cause analyses for quality issues.
- Manage audit readiness and responses to inspections.
- Lead teams on risk management and quality system initiatives.
Job Requirements
- Minimum of 10+ years in Product Design Quality/Control, with ISO 13485 and ISO 9001 experience.
- Proven leadership experience in team management and development.
- Expertise in Design Quality/Controls and Risk Management.
- Experience in hardware and software development lifecycles.
- Background in strategic quality improvement initiatives using data.
- Extensive experience in Design Verification/Validation and auditing.
- Bachelor’s degree in Quality, Engineering, or a related field; certifications desired.
