Description

• Quality Engineering working knowledge and Quality Management Experience
• working knowledge of ISO, MDD, FDA QSR 21 CFR 820 / ISO 13485 quality system requirements
• Risk Management Process
• Support non-conformance activities for their resolution
• Support CAPA activities for their closure
• Work and review incoming inspection report
• Support validation, protocol and Technical reports
• Quality reviews for documentation
• Interact with stakeholders for review and alignment
• Project Management support as needed
• support and provide guidance on Validations
• Create receiving inspection forms
• MSA, inspection equipment validation experience.
• SOP, WI create and revise, Change management activities to push the changes through

Bachelor’s Degree required in Mechanical Engineering.