Quality Engineer II
Skills
Failure Mode And Effects AnalysisGeometric Dimensioning & TolerancingQuality AssuranceQuality ControlQuality EngineeringQuality SystemRoot Cause
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Proficient in blueprint reading and geometric dimensioning and tolerancing
- Familiar with QSR/ISO regulations design assurance FMEA and product testing methods
- Excellent communication skills both oral and written
- Capability to work effectively within a team and build external relationships
- Results-oriented with a strong ability to meet deadlines
- Bachelor of Science in Engineering or related field with CQE certification preferred
Nice to have
- CQE certification
- Medical device experience
Day to day
- Conduct thorough investigations of product failures to identify root causes
- Draft medical device and vigilance reports for regulatory compliance
- Formulate and revise procedures specifications and standards for product and processes
- Develop and execute corrective/preventative action plans
- Track and trend product quality metrics