Job description

General
Participates in QA&RA Company Compliance
Internal and External audit preparation
Participate the ongoing projects’ meetings, Verify and approve Project DHF deliverables
Responsible for communicating business related issues
Responsible for ensuring that project follows all Company guidelines related to Health, Safety and Environmental practices
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Regulatory Activities
Providing Regulatory Inputs for product development and notifications
Perform Products certificates related activities
Perform an Assessments for engineering changes
QA/RA support for R&D projects
Support Products DHF management and QA/RA deliverables
Support Tools and Jigs DHF management
QA/RA support for Operation projects
QA/RA support for Operations’ projects development
Analyze and provide QA/RA input (Req.) for Operations’ projects
Define deliverables and deliver QA/RA reports
ECO review process

Requirements

BA in Engendering other relevant education
Proven experience of at least two years in the field of QA/RA
Advantage: Medical devices
Medical Devices worldwide regulations and standards
Quality processes
Compliance aspects
High level of English – read and write
Excellent communication skills and teamwork
Ability to work on multiple projects
High commitment to tasks and timelines
Auditors certification – an advantage

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