Not specified; not specified; comprehensive benefi...
Iso 13485 compliance knowledge
Process validation iq oq pq
Failure mode effect analysis fmea
The role ensures compliance with company Quality Management Systems and customer requirements in accordance with ISO 13485 while providing quality engineering support to manufacturing
Job Summary
The role ensures compliance with company Quality Management Systems and customer requirements in accordance with ISO 13485 while providing quality engineering support to manufacturing.
Responsibilities include assisting with process validations, facilitating Failure Mode and Effect Analysis, and tracking quality metrics to drive continual improvement activities.
Candidates will benefit from a comprehensive package including medical, dental, vision plans, flexible time off, and a retirement savings plan with company match.
Matching Summary
The role ensures compliance with company Quality Management Systems and customer requirements in accordance with ISO 13485 while providing quality engineering support to manufacturing.
Salary
Not specified; Not specified; Comprehensive benefits package including medical, dental, vision, paid time off, and retirement match
Skills & Requirements
Must-have
ISO 13485 compliance knowledge
Process validation IQ OQ PQ
Failure Mode Effect Analysis FMEA
Statistical Process Control SPC
Root Cause Analysis execution
Design of Experiments DOE
Nice-to-have
Cross-functional collaboration skills
Results oriented mindset
Lean Kaizen continuous improvement
Strong organizational abilities
Ability to work independently
Key Requirements
Bachelor's degree in Engineering or Science
Two or more years Quality Engineering Experience
Six Sigma Green or Black Belt certification preferred
Working knowledge of ISO 9001 QMSR and FDA regulations