Quality Engineer II
Location
Denver, CO
Level
Mid-Level
Department
MedTech
Type
Salary
$70,000 - $110,000
Job Description
Posted on:
2025-09-09
Responsibilities
- Develop, implement, and maintain quality system processes and procedures for compliance.
- Stay updated on best practices and regulations for medical devices.
- Plan and perform engineering assignments to support company goals.
- Use Quality Engineering tools for product/process development and problem-solving.
- Promote and apply DMAIC/PDCA methodologies for improvements.
- Guide Quality Technicians in the factory.
- Collaborate with manufacturing engineering on process assurance for new product launches.
Job Requirements
- Bachelor's degree in Engineering or related field.
- 2+ years of engineering experience in medical device or regulated industry.
- Preferred experience in regulated environments with knowledge of compliance standards.
- Strong communication and analytical skills.
- Knowledge of quality principles and statistical methods.
- Understanding of 21CFR820 / ISO13485 / ISO14971.
- Actively pursuing quality certifications (e.g., CQE, Lean Six Sigma).
