$114,675 - $168,190; not specified; not specified ...
Quality management systems (qms)
Fda regulations
Device history records (dhr)
Ensure Integer internal and external customer expectations are met or exceeded by identifying and evaluating procedures to ensure the production of quality product
Job Summary
Ensure Integer internal and external customer expectations are met or exceeded by identifying and evaluating procedures to ensure the production of quality product.
Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
The company provides innovative, high-quality medical technologies that enhance the lives of patients worldwide.
Matching Summary
Ensure Integer internal and external customer expectations are met or exceeded by identifying and evaluating procedures to ensure the production of quality product.
Salary
$114,675 - $168,190; Not specified; Not specified
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DHR)
Bill of Materials (BOM) review
process validation
test method validation
non-conforming material disposition
Nice-to-have
collaborate with cross-functional teams
positive can-do attitude
calm demeanor in high-energy environment
subject matter expert
advancing technology
Key Requirements
Bachelor's degree in engineering or related field
7+ years of progressive engineering experience
15+ years of relevant experience (if education requirement not met)
6-Sigma (green belt minimum, black belt preferred)
Awareness of Domestic and International Regulations and Industry Standards