Director, Quality Engineering
Location
Bothell, WA
Level
VP / Executive
Department
MedTech
Type
Salary
Job Description
Posted on:
2026-03-09
Responsibilities
- Lead and manage Quality Engineering functions (Supplier Quality, Design Quality, Process/Manufacturing Quality).
- Develop and implement Quality Engineering strategy and processes.
- Ensure compliance with FDA regulations and applicable standards.
- Collaborate with internal and external partners to optimize quality processes.
- Manage pre- and post-market quality engineering activities.
- Establish product quality and process metrics for performance improvement.
- Foster a knowledgeable and competent Quality Engineering team.
Job Requirements
- 15+ years of experience in quality/regulatory leadership in FDA regulated companies.
- Bachelor’s degree in Engineering (Master’s preferred).
- Proficient in ISO 13485, FDA’s QSR, and international regulatory standards.
- Strong problem-solving and project management skills.
- Excellent communication and interpersonal relationship skills.
- Experience in leading and managing audits and inspections.
- CQE certification preferred.
