International Quality Assurance Manager

JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE. It takes a team of talented people to become one of the world’s leading providers of innovative medical devices. Angio Dynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.

• A Commitment to the Highest Standards of Quality
• Relentless Innovation
• Operational Excellence

Our employees receive the highest level of training and endeavor to be the best and the brightest in the medical device industry. We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.

Responsible for managing the overall Quality Assurance function at Angio Dynamics Israel. This involves oversight of the Quality Management System functions including Management Responsibility, Resource Management, Design & Development, and Measurement, analysis and improvement. The role requires coordinating activities closely with Corporate QA functional SME's to streamline reporting and QMS structure, coordinating activities between QA and other departments to ensure GMP compliance.

The person must have the ability to multi-task, prioritize tasks, and quickly adjust in a rapidly changing environment.

• Responsibility for Quality Assurance Programs that include:
  • Report to members of Management and members with Executive Responsibility on the performance of the quality management system and any need for improvement.
  • Manage a team of Quality professionals, ensuring the business unit is sufficiently resourced, developing employees, performing appraisals, providing leadership, direction, and coaching.
  • Develop and manage site QA budget within overall department budget as necessary.
  • Act as Site Management Representative. Coordinate and facilitate external audits with external Regulators and Notified Bodies in conjunction with Corporate Quality.
  • Coordinate and prepare annual Management Review in partnership with Corporate QA.
  • Provide guidance to the relevant Corporate Quality functions in support of the QMS transition.
  • Support the R&D function in their Design & Development projects and coordinate with Design Assurance team to support design verification & validation and implementation of new products and design changes.
  • Support Design Assurance team in risk management activities inclusive of product and process risks.
  • Support and take the lead in CAPA's as necessary and coordinate with Corporate Quality in system implementation. Support investigations and help implement corrective actions plans.
  • Support Complaints Management Team with complaint investigations and help determine trends. Escalate critical complaints to Complaints Management Team in a timely manner when warranted.
  • Support Contract Manufacturer's with supplier changes, non-conformances, root cause analysis, audit activities, etc as necessary. Oversee regular quality reviews and report to Corporate Quality any concerns. Responsible for the release of all finished goods shipped to distribution centers.
  • Work with peers and management to develop and deliver monthly management metrics/reviews - analysis of data.
  • Ensure compliance with all relevant Regulatory, International standards, and legal requirements. Review and implement any updates to regulations and standards to ensure system compliance.
  • Responsible for implementation and maintenance of quality standards to ensure that all new and existing products meet their requirements for safety and effectiveness.
  • Interpret and communicate company policies impacting all employees.
  • Drive harmonization and best practices across the site.
  • Drive quality improvement and customer satisfaction across the site.
  • Review current test methods, equipment, procedures, and routine product testing trends to determine the need for change.
  • May perform other duties as assigned.
• Supervisory Responsibilities:
  
  Yes
• Regulatory Responsibilities:
  Manages in order to ensure…