International Quality Assurance Manager (Quality Management Systems)

About the role

Responsible for managing the overall Quality Assurance function at AngioDynamics 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 subject-matter experts to streamline reporting and QMS structure. Coordinates 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.

Responsibilities

• Report to members of Management and 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, and performing appraisals.
• Provide leadership, direction, and coaching to the team.
• 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 CAPAs as necessary and coordinate with Corporate Quality in system implementation. Support investigations and help implement corrective action 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 Manufacturers 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.

Requirements

• Bachelor’s degree in Engineering or a Science-related field.
• 5 years of demonstrated experience in quality assurance with a minimum of 3 years within the Medical Device industry.
• Minimum of 3 years supervisory/leadership experience.
• Advanced graduate degree preferred in a related field.

Skills

• Demonstrated history of execution in a leadership role; adept at personnel selection and development of personnel in key functional roles.
• 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.
• Working knowledge of Hardware and Software testing methodologies strongly preferred.
• Ability to effectively manage to deadlines while ensuring consistent delivery of top-quality results both individually and from direct report team.
• Demonstrated ability to influence decision-making at top levels of an organization by providing guidance and expertise on key matters affecting Quality functions.
• Strong technical writing skills.
• Demonstrate strong leadership through effective communication, high availability, and operational responsiveness, including flexibility to support the Israel site across non-standard working hours and on-site audits in Israel when required.
• Operate with a hands-on management approach, actively engaging in key quality activities as needed to support the team, resolve issues, and ensure timely execution in a dynamic, fast-paced environment.
• 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.

Physical/Work Requirements

• Work safely and follow all OSHA regulations and company safety policies and procedures.
• For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
• Exposure to standard office environment.
• Ability to frequently lift and/or move up to 15 lbs.
• Ability to occasionally lift and/or move up to 50 lbs.
• Ability to regularly sit and stand for extended periods of time.

Benefits

We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.