IT Consulting Jobs

Senior Systems Quality Engineer – Medical Device

Location: Alpharetta, Georgia

The Senior Systems Quality Engineer – Medical Device will lead the on-going quality activities to support a commercial medical device which contains both software and hardware. This role provides quality engineering leadership by technically understanding the device system interactions, collaborating with R&D and manufacturing on product opportunities post-commercialization, monitoring and analyzing complaint data, assisting/leading root cause analysis, implementing corrective actions and proactively supporting business strategies.

These activities include but are not limited to: Developing and maintaining Risk Management Files; supporting software updates, implementing system design changes, employing product enhancements, overseeing process changes; investigating product non-conformances; ensuring compliance to quality system requirements; and supporting the qualification of suppliers.

Actively participates in and/or facilitates the development of deliverables required to qualify product changes, both software and hardware, ensuring that customer requirements and specifications are met

  • Develops and maintains the Risk Management Files, which includes Hazards Analysis, Use FMEA, Design FMEA (software & hardware), and Process FMEA, for assigned product families
  • Solves challenging technical problems, provides expertise in related specific field of knowledge and consults on complex issues and projects
  • Works within cross-functional teams to lead investigation of customer product complaints
  • Utilizes Root Cause Analysis concepts to investigate issues and implement Corrective and Preventive Actions including effectiveness checks
  • Ensures timely closure of active complaints providing tracking and trending data
  • Leads Global Post Market Surveillance analysis, trending, and reporting
  • Formulates responses to Regulatory Agencies in regards to Health Agency Reporting and performs Health Hazard Evaluations as needed
  • Partners with vendors to facilitate the completion of Supplier Corrective Actions and to build quality relationships
  • Develops, initiates, and implements new quality concepts, tools and strategies to improve business practices
  • Assists with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert
  • Conducts self in accordance with the expected Halyard behaviors
  • Communicates business initiatives, project milestones, and/or quality concepts to business partners including manufacturing facilities.
  • Ensures that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position

Required Qualifications

  • B.S. in Engineering, Science, or equivalent
  • Minimum of 7 years of collective experience in product development, manufacturing and/or quality within a medical device environment
  • Experience supporting Electro-Mechanical Devices and servicing preferred
  • Proficient with Microsoft Office Programs
  • Strong understanding of statistical concepts preferred
  • Experience in Agile methodologies preferred