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QA Engineer

Job Description

 

Role: QA Engineer - 940966

Location: Wayland, MA

 

Job Description:

  • Experience in quality assurance
  • Strong understanding of medical device design assurance
  • Experience in management of QE professional and technical staff
  • Expertise in standards and regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR 820, EU MDR, etc) affecting medical devices marketed in all regions throughout the world
  • Specific experience in MDR.

Job Requirements

  • working knowledge in risk management file of medical devices, complaint analysis, standards (like IEC 60601-1) gap analysis, knowledge on medical device labels like product labels, IFU, service manual, etc.

experience on EU MDR, CE marking documentation

Job Snapshot

Location US-MA-Wayland
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Other
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Company Overview

American Cybersystems, Inc. (ACS Group)

ACS Group provides services to Fortune 1000 companies across various industry verticals. With a proven track record of managing project demands while improving the efficiency, productivity and profitability of new and existing projects through process improvement, ACS Group is consistently recognized for identifying and implementing strategic solutions that create and preserve long-term business value. Learn More

Contact Information

US-MA-Wayland
Rakhi Dangwal
949-427-2193
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Snapshot
American Cybersystems, Inc. (ACS Group)
Company:
US-MA-Wayland
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

 

Role: QA Engineer - 940966

Location: Wayland, MA

 

Job Description:

  • Experience in quality assurance
  • Strong understanding of medical device design assurance
  • Experience in management of QE professional and technical staff
  • Expertise in standards and regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR 820, EU MDR, etc) affecting medical devices marketed in all regions throughout the world
  • Specific experience in MDR.

Job Requirements

  • working knowledge in risk management file of medical devices, complaint analysis, standards (like IEC 60601-1) gap analysis, knowledge on medical device labels like product labels, IFU, service manual, etc.

experience on EU MDR, CE marking documentation

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QA Engineer Apply now