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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 will require coordinating activities very closely with Corporate QA functional SME's to streamline the 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.

Essential Duties and Responsibilities

• 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, development of employees, and perform 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 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.

• Drives harmonization and best practices across the site.
• Drives 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 compliance with all relevant regulatory/legal requirements

Management

Establish and support a work environment of continuous improvement that supports the Quality Policy, Quality System and the appropriate regulations for the area they support.  Ensure all employees are trained to do their work and their training is documented

Education and Experience

• Bachelor's Level of Degree in the Engineering or Science related field of study
• 5 years of demonstrated experience in quality assurance with a minimum of 3 years experience within the Medical device industry. In addition a minimum of 3 years supervisory/leadership experience.
• Any preferred education, experience or certifications:  Advanced graduate degree preferred in a related field.

Skills/Knowledge

• 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, 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 communication 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.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job:

• 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 (insert any extreme climate and/or work conditions)  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 (insert physical abilities, repetitive movement, vision requirements, etc.)

EMPLOYEE ACKNOWLEDGMENT

By signing the Learning & Development training form, I understand that the company reserves the right to add to or revise an employee’s job duties at any time at its sole discretion. All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.  This document does not create a contract of employment between AngioDynamics and any individual, express or implied.  All employees are, and remain, employees-at-will.