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
- 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