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

Who you Are:

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

Who we are

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.

Roche is an Equal Opportunity Employer.