Min 59,250; max 86,900; benefits: medical, dental,...
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Quality management systems (qms)
Fda regulations
Device history records (dhr)
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Integer is seeking a Quality Engineer I for their Alden, NY location, focusing on ensuring compliance with quality standards in medical device manufacturing. The role involves collaboration with experienced engineers, supporting regulatory inspections, and participating in continuous improvement initiatives.
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Job Summary
As an entry level engineer, you will ensure that Integer’s internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization.
You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
You will support generation and completion of protocols and reports for test method validations and interface with Manufacturing Engineers to review processes for new and existing products.
Matching Summary
Match Score: 75
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Integer is seeking a Quality Engineer I for their Alden, NY location, focusing on ensuring compliance with quality standards in medical device manufacturing. The role involves collaboration with experienced engineers, supporting regulatory inspections, and participating in continuous improvement initiatives.
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Salary
Min 59,250; Max 86,900; Benefits: 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)
Bill of Materials (BOM) review
Continuous improvement projects
Test method validations
Non-conforming material disposition
CAPA activities
Nice-to-have
Collaborate with cross-functional teams
Positive, can-do attitude
Calm demeanor in high-energy environment
Passionately pursuing excellence
Key Requirements
Bachelor's degree in engineering or related technical/Science field
0-3 years of experience
Awareness of Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)