Quality Engineer Ii- Alden

Integer

Alden, NY, United States
Min 70,500; max 103,400; benefits: medical, dental...
Quality management systems (qms)
Fda regulations
Device history records (dhr)
Perform work involving general engineering methods and tools, utilizing advanced quality tools and concepts to resolve problems and ensure customer expectations are met or exceeded

Job Summary

  • Perform work involving general engineering methods and tools, utilizing advanced quality tools and concepts to resolve problems and ensure customer expectations are met or exceeded.
  • Support regulatory and agency inspections, monitor manufacturing compliance, review changes to product documentation, and participate in continuous improvement and product transfer projects.
  • Lead the generation of test method validation protocols, interface with manufacturing engineers for process validation, develop inspection techniques, and manage non-conforming material processes and complaint investigations.

Matching Summary

Perform work involving general engineering methods and tools, utilizing advanced quality tools and concepts to resolve problems and ensure customer expectations are met or exceeded.

Salary

Min 70,500; Max 103,400; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company match, 80 hours holidays, paid time off

Skills & Requirements

Must-have

  • Quality Management Systems (QMS)
  • FDA regulations
  • Device History Records (DHR)
  • Test method validation protocols
  • Non-conforming material disposition
  • Root cause analysis

Nice-to-have

  • Collaborate with cross-functional teams
  • Calm demeanor in high-energy environment
  • Positive, can-do attitude
  • Continuous improvement suggestions

Key Requirements

  • Bachelor's degree in engineering or related field
  • 3 years relevant experience
  • 7+ years relevant experience (if no degree)
  • Awareness of Domestic and International Regulations
  • Good knowledge in Microsoft Office

Work Rights

Not specified

Tailored Resume

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