Sr Quality Engineer

JOB DESCRIPTION

Capability to conduct thorough reviews of new and modified product design documentation assessing quality characteristics such as manufacturability serviceability testability reliability and compliance with product requirements.
Subject matter expert in risk management for designated medical device products or platforms.
Ensuring compliance with FDA Quality System Regulations EU MDR ISO 13485 ISO 14971 IEC 60601 and other relevant industry standards during product development and changes.
Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements.
Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies.
Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles including contributor subject matter expert leader and facilitator.
Provide Quality support to facilitate resolution of product complaints and/or safety issues
Previous experience working in a cross-functional team environment.
Familiar with statistical software tools (Minitab)
Develop templates and trainings based on the quality system regulations applicable standards and guidance.
Independently review all deliverables to ensure compliance with development process and the standard.
Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor subject matter expert leader facilitator.
Hands-on experience on complaints analyis Post market surveillance Design Controls for Medical Devices.

Technical skills:
Risk Management
PFMEA
Master Validation plan/Report Control Plan
DMAIC or DMADV
ISO Standards
Working knowledge of and auditing experience to the FDA Quality System Regulation ISO 13485 and the Medical Device Directive.