Quality Assurance Manager

Abcam

Waltham, United States
Base: $110,000-$120,000; bonus/equity: eligible fo...
ISO 9001
Iso 13485
Mdsap
The Quality Assurance Manager is responsible for overseeing an ISO 9001 certified Quality Management System producing research kits and an ISO 13485 and MDSAP certified division producing Class I IVDs, ensuring compliance and excellence

Job Summary

  • The Quality Assurance Manager is responsible for overseeing an ISO 9001 certified Quality Management System producing research kits and an ISO 13485 and MDSAP certified division producing Class I IVDs, ensuring compliance and excellence.
  • The Quality Assurance Managers leadership will be pivotal in enhancing customer satisfaction and achieving organizational success.
  • We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits to eligible employees.

Matching Summary

The Quality Assurance Manager is responsible for overseeing an ISO 9001 certified Quality Management System producing research kits and an ISO 13485 and MDSAP certified division producing Class I IVDs, ensuring compliance and excellence.

Salary

Base: $110,000-$120,000; Bonus/Equity: eligible for bonus/incentive pay; Benefits: comprehensive package of benefits including paid time off, medical/dental/vision insurance and Retirement Benefits

Skills & Requirements

Must-have

  • ISO 9001
  • ISO 13485
  • MDSAP
  • 21 CFR 820
  • Quality Management System
  • Customer satisfaction

Nice-to-have

  • Agile and audacious mindset
  • Continuous improvement culture
  • Scientific community support

Key Requirements

  • Bachelor's degree in Quality Management, Engineering, Life Sciences, or related field
  • Minimum of 5 years in quality assurance
  • At least 3 years of management/supervisory experience
  • Lead Auditor Certification
  • Experience leading investigations and CAPAs
  • Experience supporting validation plans

Work Rights

Not specified

Tailored Resume

Cover Letter