Quality Engineer I
Location
Woodinville, WA
Level
Entry-Level
Department
MedTech
Type
Salary
$77,000 - $89,000
Job Description
Posted on:
2025-05-29
Responsibilities
- Attend cross-functional Daily Management meetings representing Quality Assurance.
- Manage the Material Review Board and ensure data-driven documentation of non-conformities.
- Analyze nonconformances and complaints for trends to prevent recurrence.
- Support the release of high-quality products through risk-based decision making.
- Maintain the integrity of the Quality Management System through well-designed investigations.
- Facilitate risk management practices to satisfy all quality requirements.
- Promote a quality culture and improve processes continuously.
Job Requirements
- Bachelor’s degree or equivalent in a related scientific discipline.
- 0-2+ years of experience or equivalent combination of education and experience.
- Strong understanding of GMP / ISO regulations and validation principles preferred.
- Basic understanding of risk management best practices for the medical device industry.
- Quality Engineering, Six Sigma Green Belt Certifications desirable.
- Skilled in statistical methods and statistical process control preferred.
- Ability to work well in fast-paced, cross-functional teams.
