International Quality Assurance Manager

JOB SUMMARY - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

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 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

QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES

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

QUALIFICATIONS
-The requirements listed below are representative of the knowledge, skill or ability required.

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…