International Quality Assurance Manager

AngioDynamics • Marlborough, MA

22h • $121,000 - $152,000 • Onsite

About The Position

AngioDynamics is a leading provider of innovative medical devices dedicated to improving patient outcomes. We focus on developing disruptive technologies that address unmet patient needs and support healthcare providers globally. Our commitment is to the highest standards of quality, relentless innovation, and operational excellence. Employees receive top-tier training to excel in the medical device industry. We offer a comprehensive benefits plan to support employee and family health and wellness.

Requirements

• Bachelor's Level of Degree in an Engineering or Science related field of study.
• 5 years of demonstrated experience in quality assurance.
• Minimum of 3 years experience within the Medical device industry.
• Minimum of 3 years supervisory/leadership experience.
• Demonstrated history of execution in a leadership role; adept at personnel selection and development.
• Successful track record of improvement to organizational Quality functions; ability to correct functional issues with appropriate remedial action.
• Experience in managing through change and proven track record of driving results in changing environments.
• Strong analytical, quantitative, and project management skills.
• Ability to effectively manage to deadlines while ensuring consistent delivery of top quality results.
• Demonstrated ability to influence decision-making at top levels of an organization.
• Strong Technical writing skills.
• Demonstrate strong leadership through effective communication, high availability, and operational responsiveness.
• Operate with a hands-on management approach, actively engaging in key quality activities.
• Exceptional interpersonal skills.
• Strong organizational skills.
• Strong communication skills (written and verbal).
• Ability to effectively communicate both internally and externally.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Work safely and follow all OSHA regulations and company safety policies and procedures.
• Notify manager/supervisor immediately for all on-the-job injuries or accidents.

Nice To Haves

• Advanced graduate degree preferred in a related field.
• Working knowledge of Hardware and Software testing methodologies strongly preferred.
• Flexibility to support the Israel site across non-standard working hours, on site audits in Israel, when required.

Responsibilities

• Manage the overall Quality Assurance function at AngioDynamics Israel, including oversight of the Quality Management System (QMS) functions: Management Responsibility, Resource Management, Design & Development, and Measurement, Analysis, and Improvement.
• Coordinate closely with Corporate QA functional SMEs to streamline reporting and QMS structure.
• Coordinate activities between QA and other departments to ensure GMP compliance.
• Report on the performance of the quality management system and any need for improvement to management and executive responsibility members.
• Manage a team of Quality professionals, ensuring sufficient resources, employee development, and performance appraisals. Provide leadership, direction, and coaching.
• Develop and manage the site QA budget.
• Act as Site Management Representative, coordinating and facilitating external audits with regulators and notified bodies in conjunction with Corporate Quality.
• Coordinate and prepare the annual Management Review in partnership with Corporate QA.
• Provide guidance to Corporate Quality functions in support of the QMS transition.
• Support the R&D function in Design & Development projects, coordinating with the Design Assurance team for design verification, validation, and implementation of new products/changes.
• Support the Design Assurance team in risk management activities (product and process risks).
• Support and lead CAPA activities as necessary, coordinating with Corporate Quality for system implementation, investigations, and corrective action plans.
• Support the Complaints Management Team with complaint investigations, trend determination, and timely escalation of critical complaints.
• Support Contract Manufacturers with supplier changes, non-conformances, root cause analysis, and audit activities. Oversee regular quality reviews and report concerns to Corporate Quality.
• Responsible for the release of all finished goods shipped to distribution centers.
• Develop and deliver monthly management metrics/reviews, including data analysis, in collaboration with peers and management.
• Ensure compliance with all relevant Regulatory, International standards, and legal requirements. Review and implement updates to regulations and standards.
• Implement and maintain quality standards to ensure new and existing products meet safety and effectiveness requirements.
• Interpret and communicate company policies impacting 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 product testing trends to identify needs for change.
• Perform other duties as assigned.

Benefits

• Comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager