Site Team Leader, Quality Assurance (Rehovot, Israel)

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

Responsible for day-to-day site Quality Assurance activities at AngioDynamics Israel. This involves coordinating required activities and priorities with the Manager, Global Quality. The role will require coordinating activities with Corporate QA functional SME's as required. This role requires the ability to multi-task, prioritize tasks and quickly adjust and make decisions in a rapidly changing environment.

Essential Duties And Responsibilities

• Responsibility for Quality Assurance Programs that include:
• First point of contact for manufacturing quality issues.
• Provide day-to-day direction to the team. Promoting quality culture.
• Act as Site Management Representative. Coordinate with Manager, Global Quality Assurance and facilitate external audits with external Regulators and Notified Bodies in conjunction with Corporate Quality.
• Provide internal audit support.
• Support the QMS transition.
• Escalation of significant quality issues.
• 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 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.
• Provide supplier quality support.
• Responsible for implementation and maintenance of quality standards to ensure that all new and existing products meet their requirements for safety and effectiveness.
• Drives harmonization and best practices across the site.
• Drives quality improvement and customer satisfaction across the site.

• May perform other duties as assigned.
  

• Bachelor's Level of Degree in the Engineering or Science related field of study
• Equivalent work-related experience acceptable in lieu of degree X Yes No
• 7 years of demonstrated experience in quality assurance with a minimum of 5 years experience within the medical device industry. In addition, a minimum of 3 years supervisory experience.
• Any preferred education, experience or certifications: None.
  
  

• Successful track record of improvement to organizational Quality functions; ability to make day-to-day quality decisions.
• 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.
• Strong Technical writing skills.
• 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.