Senior Quality Engineer
The Senior Quality Engineer will provide quality engineering leadership to sustain a best practice Quality System at CardioKinetix Inc., which shall meet the applicable requirements of the FDA QSR, ISO 13485, MDD, and the CMDR. This individual will ensure that products meet all applicable internal and external requirements, from product conception through post-market activities.
- Manage and lead risk management activities including Process FMEA, Design FMEA, Hazard Analysis, and Human Factors Risk Assessment.
- Manage and lead validation activities including Process OQ, Process PQ, Software Validation, Test Method Validation, Supplier Process Validation, and Sterilization Validation.
- Review and Trend process monitoring and environmental monitoring results.
- Champion continuous improvement effort for manufacturing and quality processes.
- Serve as Quality Engineering expert for the Design/Development and Risk Management Teams.
- Support product release activities; review and approve incoming inspection records, LHRs, and labeling activities.
- Support Supplier Management program, including initial qualification, audits, SCAR issuance and follow-up, and monitor and report on related activities.
- Support the CAPA process and ensures timely initiation and closure of CAPAs.
- Support the Nonconformance Report (NCR) process and ensures timely initiation and closure of NCRs.
- Support product release activities and incoming inspection activities.
- Develop and implement procedures/processes to maintain state-of-the art quality system.
- Support all other quality functions as necessary.
SKILLS & EXPERIENCE
Bachelor’s degree in engineering or of scientific discipline.
5+ years of quality experience in medical device, biotechnology or related industry; working knowledge of Minitab, SolidWorks preferred; strong technical proficiency of Quality Management Systems with focus on Quality Assurance functions; Demonstrated competency of 21 CFR 820, ISO13485, ISO 14971, and other international standards; proficiency in statistical sampling plans and statistical process control.
Menlo Park, CA