$77,570 - $113,740; not specified; medical, dental...
Quality management systems (qms)
Fda regulations
Device history records (dhr)
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance
Job Summary
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success.
Matching Summary
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance.
Salary
$77,570 - $113,740; Not specified; Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, 80 hours holidays, paid time off
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DHR)
test method validations
non-conforming materials disposition
CAPA activities
statistical quality control
Nice-to-have
continuous improvement projects
product transfers assistance
supplier quality resolution
team environment collaboration
effective communication skills
Key Requirements
Bachelor’s Degree in Engineering or related field
2-5 years quality engineering experience
medical device or regulated manufacturing experience