$93,225 - $136,730; not specified; medical, dental...
Quality management systems (qms)
Fda regulations
Device history records (dhr)
Support product development projects including phase 3, 4, and 5 quality deliverables, adhering to QMS, EMS, FDA regulations, and company policies
Job Summary
Support product development projects including phase 3, 4, and 5 quality deliverables, adhering to QMS, EMS, FDA regulations, and company policies.
Lead and implement product and process improvement methodologies, review changes to BOMs, Assembly Procedures, Drawings, FMEAs, and Control Plans.
Manage complaint investigations, lead plant CAPA activities, and work with suppliers, management, and manufacturing associates to resolve quality problems.
Matching Summary
Support product development projects including phase 3, 4, and 5 quality deliverables, adhering to QMS, EMS, FDA regulations, and company policies.
Salary
$93,225 - $136,730; Not specified; Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with match, paid time off
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DHR)
Risk analysis
Test method validation
Statistical quality control
Nice-to-have
Customer success focus
Innovative solutions
Collaborative team environment
Respectful interaction
Open and honest communication
Key Requirements
Bachelor’s Degree in Engineering or related field
5-7 years’ experience in medical device or regulated manufacturing
Certified Quality Engineering (CQE) or Six Sigma Black Belt desired