תיאור המשרה:
Provide professional and management support to Quality System specialist with CAPA activities, including CAPA meetings, action items and CAPA processes (e.g., investigation, implementation, and effectiveness).
Engage, monitor, and manage an effective CAPA Process including managing / participating in CAPA Meetings to ensure timely closure of open CAPA’s.
Provide support to CAPA owners and work with global partners.
Monitor CAPA progress while ensuring completeness and timeliness.
Meet and maintain Company established Metrics goals and targets for closing CAPA’s.
Ensures Quality Agreements are followed by establishing supporting processes
דרישות המשרה:
Degree in engineering or life science
Preferred : CQE certification
At least 5 years’ experience in the medical device industry or pharmaceutics
Experience as Quality Leader and/or quality assurance leader responsible for Quality Audits management
Experience working with Notified Bodies, FDA and/or other authorities
Experience managing international multi-disciplinary projects
Experience with ISO and/ or QSR standards/regulations for the medical
devices or pharmaceutics industries
Experience with CAPA execution in medical devices and/or pharmaceutics company. Preferred
Quality Standards requirements: high level
Data Analysis Statistical Tools – preferred
על החברה
חברת מכשור רפואית גלובלית בעלת מוצרים רב תחומיים בתחום הקרדיולוגי.