Quality Assurance Specialist

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

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 Quality Assurance Specialist, 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 quality compliance at the affiliate level according to local regulation and Roche’s policies and procedures.

Responsibilities:

You will be responsible for the Affiliate Quality compliance, implementation of local relevant processes in adherence with the Global standards, providing support in complaint handling.

You will serve as primary contact for local Quality matters.

You will be leading additional areas:

• Responsible for GSP compliance in accordance with Roche’s QMS
• Cooperate with logistic functions for certification of Good Importation and Good Distribution Practices including communication with the Certification Bodies
• Training & Communication - oversees quality & related training, communication processes
• Support for safety and quality notifications including recalls and the collection of local customer and patients acknowledgements
• 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
  
  

• An academic degree in quality/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 in human or veterinary diagnostic processes would be an asset