לצערנו המשרה כבר לא בתוקף

Local Quality & Safety Officer- Diagnostics Israel

1-2 שנים |
משרה מלאה
| לפני 13 דקות
תיאור משרה

The Opportunity:
If "Doing now what patients need next" is your purpose in life, we have good news for you. It's also our purpose and we are currently hiring!
Roche is ranked among the world's foremost corporations providing innovative healthcare solutions, continuously investing in medical research and development.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
As a Local Quality & Safety Officer, you will be part of a team supporting the establishment of the new diagnostic entity in Israel. This is a unique opportunity to impact the design and creation of the new organization, leading the in-vitro Diagnostics market in Israel. We are looking for someone who will join our professional & fun team .
Position Purpose:
Ensures the safety and quality is in accordance with Roche policies and procedures in accordance with the Medical Device Regulatory Requirements in Israel .
Responsibilities
You will be responsible for the Affiliate Quality & Safety adoption, assessment of the medical risk of complaints, implementation of local relevant processes in adherence with the Global standards.
You will serve as primary contact for Medical Safety and Quality matters.

You will be leading additional areas:
- Responsible for local complaint Mngt. & periodical reviews according to the Israelrian regulation
- Local regulatory processes management: cooperates with logistic functions for certification of Good Importation and Good Distribution Practices including communication with the Certification Bodies
- Training & Communication - oversees quality & regulatory related training & communication processes.
- Responsible for safety and quality notifications including recalls and the collection of local customer and patients acknowledgements
- Responsible for local quality and regulatory metrics (“KPIs”) and actions (if required), incl. local Management Review (according to ISO and Roche internal standards.
- Quality audits management: Planning and execution of regular internal & external quality audits
- Ensuring compliance with all Roche corporate business principles, Code of Conduct, policies and practices.

דרישות התפקיד

Who you Are
? An academic degree in Life/ Medical Science, Biology, Biochemistry or BioMedical engineering
? Experience in medical device and/or pharmaceuticals quality assurance
? Proven experience with ISO 9001:2015/ ISO 13485:2016 implementation
? Proven experience as Quality Auditor (ISO or GMP)
? Excellent Communication skills in English & Hebrew
? Excellent interpersonal relationships and the ability to communicate and negotiate effectively at all levels
? Good problem solving skills, real team player,
? Hands on mentality and Customer focus and the ability to focus on customers` demand.
? Practical experience or inside into human or veterinary diagnostic processes would be an asset

* משרה זו פונה לנשים וגברים כאחד.