Required Sr. QA &RA Compliance Engineer
Job ID: 41663
Quality Assurance and Regulatory affairs Activities-
Interface and take lead QA role in interactions with cross function members
Update and maintaining the quality system for external requirements systems management to continue to drive to be best in class.
Assess applicability of regulations and standard requirements
Perform a gap assessment of applicable regulations and standards and develop implementation plans
Write and revise quality system standard operating procedures and related documentation to ensure best practices and alignment with new requirements and standards,
Business Unit Development & Support-
Establish stakeholders and communication plan for BU and the rest of the organization on regulatory requirements on existing and newly issued regulations/professional standards.
Train and coach applicable BU members in company policies, procedures, processes, and practices.
Lead and participate in the development and/or review of training, presentations, and other learning materials.
Manage multiple projects of varying complexity and other actions to help the BU with successful implementation as agreed on with affected stakeholders.
Requirements: 12+ years of experience in a complex high technology materials, hardware and software-based product environment to include a minimum of 10 years in quality with a medical device company.
Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies
Experience in world-wide medical device submissions
Experience with medical device design verification/validation
Demonstrated and impactful project management and leadership skills,
Experience with setting up, establishing, and maintaining medical device quality infrastructure
Strong knowledge of US FDA and EU Medical Device Regulations (including ISO 13485 and 14971)
Advanced computer skills, including statistical/data analysis and report writing skills
המשרה מיועדת לנשים ולגברים כאחד.