Design Quality (QA-RA) Engineer

  • location: Cary, NC
  • type: Temp to Perm

job description

Design Quality (QA-RA) Engineer

Randstad Technologies is looking for a QA/RA Engineer. This role is responsible for providing QA/RA oversight for product development activities, maintaining the non-product validation program, and coordinating product recall activities at the Cary, NC location.

ESSENTIAL DUTIES AND RESPONSIBILITIES: - Other duties may be assigned:

  • Serves as the Quality & Regulatory stakeholder for product development release team
  • Ensures quality products are developed in accordance to governing regulations and processes
  • Prepares all QARA product development deliverables
  • Serves as key member of product risk assessment teams
  • Drives key quality requirements (e.g. Design for Test, Design for Reliability, etc.) in new product development
  • Participates and supports various development activities including design reviews and Product Safety Committee
  • Reviews and approves product design documentation
  • Actively participates and/or leads Design History File audits and follow-on remediation efforts as required
  • Support root cause analysis activities for the investigation of product complaints
  • Assists in the planning and execution of verification and validation testing to ensure adequate test coverage for new products and sustaining design changes.
  • Assists in planning and execution of engineering change orders for hardware and software-related product changes
  • Performs New Product Development (NPD) gate audits to ensure project deliverables adhere to governing processes
  • Responsible for managing all tool and process validations - reviews and approves all validation documentation
  • Maintains Master Validation List (MVL) and facilitates annual review of MVL
  • Reviews quality data to identify high priority issues relating to safety, complaints and systemic customer satisfaction
  • Responsible for product change assessments, health hazard evaluations and product recall documentation
  • Assists with CAPA investigations and ensures corrections and/or corrective actions for identified nonconformances are implemented
  • Participates in site visits with customers and customer feedback workshops
  • Identifies and implements process improvement initiatives, especially scalable, risk-based processes
  • Works with other Hill-Rom entities to establish Communities of Practice in Risk Management, Software Quality Assurance, Software Development, and other strategic areas as required.

  • B.S. in Engineering (Electrical, Biomedical, etc.) or other technical degree
  • 3+ years' experience in quality engineering / quality assurance role under the Quality System Regulation, medical device or other FDA regulated industry required
  • Experience in New Product Development/ Medical Device Design Controls required
  • Experience with software-based products required
  • Extensive experience with quality tools and methods required (e.g. DFSS, root cause analysis, Software FMEAs, etc.)

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