Software Quality Engineer III

Hybrid in Mounds View, MN, US • Posted 19 hours ago • Updated 19 hours ago
Contract Corp To Corp
Contract W2
12 Months
Hybrid
$60 - $65/hr
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Job Details

Skills

  • SYSTEMS ENGINEER
  • REQUIREMENTS ENGINEER
  • SYSTEMS REQUIREMENTS ENGINEER
  • DESIGN ASSURANCE ENGINEER
  • SYSTEMS INTEGRATION ENGINEER
  • QUALITY ENGINEER
  • MEDICAL DEVICE COMPANY
  • MEDICAL DEVICE COMPANIES
  • BOSTON SCIENTIFIC
  • MEDTRONIC
  • BIOTECH
  • MEDICAL DEVICES
  • MEDICAL DEVICE
  • THERMO FISHER
  • HOLOGIC
  • SIEMENS
  • COVIDIEN
  • MERCK
  • PFIZER
  • JOHNSON AND JOHNSON
  • STRYKER
  • ABBOTT
  • ZIMMER BIOMET
  • 3M
  • EDWARDS LIFESCIENCES
  • BAXTER
  • GE HEALTHCARE
  • PHILIPS HEALTHCARE
  • DANAHER
  • VARIAN MEDICAL SYSTEMS
  • CARDINAL HEALTH
  • ILLUMINA
  • DENTSPLY SIRONA
  • ALIGN TECHNOLOGY
  • HILL-ROM HOLDINGS
  • BECTON
  • SMITH MEDICAL
  • RESMED
  • BAUSCH
  • EXACT SCIENCES
  • ABIOMED
  • TELEFLEX
  • INTEGRA
  • ORASURE
  • GLOBUS MEDICAL
  • CANTEL MEDICAL
  • CONVATEC
  • DRAEGER MEDICAL
  • CAGENT VASCULAR
  • B. BRAUN MEDICAL
  • JOHNSON & JOHNSON
  • LIGHTNINGCATH
  • MIDWEST INTERVENTIONAL SYSTEMS
  • CATHETER
  • RESOLUTION MEDICAL
  • NOVELCATH
  • STARKEY
  • COLOPLAST
  • MINCO
  • PROTOLABS
  • REQUIREMENTS TRACEABILITY
  • REQUIREMENTS MANAGEMENT
  • TRACEABILITY MATRIX
  • REQUIREMENTS TRACING
  • DESIGN CONTROLS
  • DHF
  • DESIGN HISTORY FILE
  • VERIFICATION
  • VALIDATION
  • V&V
  • RISK MANAGEMENT
  • DESIGN INPUTS
  • DESIGN OUTPUTS

Summary

Description:
Key Responsibilities

•Create and maintain requirements tracing in Cognition Cockpit
•Assist team in translating offline efforts for requirements/RCM/DOSR to Cognition Cockpit
•Establish and maintain end-to-end traceability across:
oUser Needs
oIntended Use and Product Claims
oSystem and Subsystem Requirements
oDesign Inputs and Outputs
oRisk Controls
oVerification Activities
oValidation Activities
oRegulatory Requirements
•Review requirements documentation to ensure clarity, completeness, testability, and compliance with internal standards.
•Develop and maintain traceability matrices and requirements management artifacts supporting Design History Files (DHF).
•Partner with cross-functional teams to ensure design changes are assessed for traceability impacts and appropriate updates are implemented.
•Facilitate requirements reviews and traceability assessments throughout product development and integration activities.
•Support gap assessments to identify missing, incomplete, or improperly linked requirements and verification evidence.
•Verify that requirements are appropriately linked to verification and validation activities and that objective evidence exists demonstrating compliance.
•Support regulatory submissions, audits, and inspections by providing traceability documentation and rationale.
•Collaborate with Risk Management teams to ensure hazards, hazardous situations, and risk control measures are properly traced to design requirements and testing.

Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications
Bachelor''s degree in EE or SW Engineering.
5 years w/bachelor''s degree and 3 with Masters.
Medical device experience
Requirements tracing experience
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: talmn001
  • Position Id: 26-08981
  • Posted 19 hours ago

Company Info

About Talent Software Services, Inc

We pride ourselves in making sure that diversity in the workplace is at the forefront of our business. Our Founder, Dave Iacarella, is an Army Veteran who is committed to giving back to fellow Veterans. We are proud of our history of transitioning military Veterans into the workforce with companies that value their service. TALENT helps companies meet their veteran and diversity spend initiatives and requirements. We are committed to supporting veteran and diverse organizations.

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