Responsibilities

• Quality support to assigned product development teams ensuring product manufactured conforms to quality standards, specifications, customer expectations, and associated regulations, e.g., FDA, ISO and MDD
• Non-conforming product review and disposition, associated investigation and root cause analysis, and implementation of appropriate and effective corrective actions
• Develop metrics around (Quality system) processes and drive improvements in these metrics
• Initiation, review, and approval of document change controls.
• CAPA Management
• Performance of internal audits of the QMS. Provide guidance and support on audit outcomes as relevant
• Performance of supplier audits and associated supplier management including supplier corrective action responses, etc
• Working with both suppliers and customers on the resolution of product quality issues and quality improvement programs
• Performance of analysis on QMS data in prep for management review.
• Review and verification of quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas

Qualifications

• Bachelor’s degree in science-related discipline or equivalent
• 3+ years relevant experience working in medical device-related quality function
• QMS Auditor Certification desirable
• Product and Process Validation, including FMEA, DOE, Test Method Validation, sampling plan analysis, etc
• Risk Management for Medical Devices and associated tools
• Six Sigma Problem-Solving Methodologies/Process Improvement