Quality Assurance Engineer

ZOLL

Pawtucket, RI, United States
Base: $75,000.00 to $95,000.00; bonus/equity: elig...
On-site
Quality improvement programs
Manufacturing process validations
Change control activities
ZOLL is seeking a Quality Assurance Engineer to support their Acute Care Technology division, focusing on improving product quality and compliance in a regulated medical device environment. The ideal candidate should have a background in science or engineering, relevant experience in quality assurance, and strong problem-solving skills

Job Summary

  • Responsible for supporting the Quality Assurance organization with quality improvement, supporting manufacturing, troubleshooting quality issues and monitoring quality trends; and interfacing with R&D to support new product introductions.
  • Lead product complaint investigations, driving completion from receipt to resolution and complete health risk assessments from product complaints or internal product/process/system issues.
  • Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements.

Matching Summary

Match Score: 85

ZOLL is seeking a Quality Assurance Engineer to support their Acute Care Technology division, focusing on improving product quality and compliance in a regulated medical device environment. The ideal candidate should have a background in science or engineering, relevant experience in quality assurance, and strong problem-solving skills.

Salary

Base: $75,000.00 to $95,000.00; Bonus/Equity: Eligible for annual bonus; Benefits: Comprehensive benefits plans

Skills & Requirements

Must-have

  • Quality improvement programs
  • Manufacturing process validations
  • Change control activities
  • Technical guidance to QA/QC
  • Quality data analysis
  • Material Review Board activities
  • Risk Management activities
  • Production quality monitoring
  • Internal and external audits

Nice-to-have

  • Improving patient outcomes
  • Innovative lifesaving products
  • World-class customer service
  • Entrepreneurial spirit

Key Requirements

  • BS degree in science or engineering
  • 3+ years experience in regulated environment
  • Proficient at problem solving
  • Familiar with Statistical Analysis
  • Experience with ISO 13485, ISO 14971, FDA QSR
  • ASQ Certified Quality Engineer desirable

Work Rights

Not specified

Tailored Resume

Cover Letter