Quality Engineer Ii

075

Base salary + cash-based incentive program; compre...
Bachelor's degree in engineering
3 years relevant experience
Fda regulations and qms knowledge
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry

Job Summary

  • The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
  • You will ensure internal and external customer expectations are met by adhering to FDA regulations, Quality Management Systems, and company policies.
  • The role includes leading test method validations, managing non-conforming material processes, and supporting continuous improvement projects to achieve differentiated quality.

Matching Summary

The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.

Salary

Base salary and cash-based incentive program; Comprehensive benefits package including medical, dental, vision, disability, life insurance; 401(k) plan with company matching

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • 3 years relevant experience
  • FDA regulations and QMS knowledge
  • ISO and QSR standards awareness
  • Root cause analysis skills
  • CAPA process management

Nice-to-have

  • Continuous improvement mindset
  • Strong written and oral communication
  • Ability to work independently
  • Positive can-do attitude
  • Experience with 5 Sigma methodologies
  • Collaborative team player

Key Requirements

  • Bachelor's degree in engineering or related field
  • Minimum 3 years of relevant experience
  • Knowledge of ISO, QSR, UL, MDD, TGA standards
  • Proficiency in Microsoft Office
  • Ability to work independently and collaboratively

Work Rights

Not specified

Tailored Resume

Cover Letter