About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
Role Summary: Are you a person with passion for Quality? Do you value a good working environment, engaged colleagues and development possibilities? We are offering an exciting workplace where you will play a key role in our business and for our customers.
As QA Specialist, you will be the QA representative in our new product introduction (NPI) projects managed from the Uppsala site. You will be responsible to ensure compliance to GEHC- Life Sciences Quality Management System.
We expect you to be the differentiator using your quality expertise to support our Life Science business to effectively develop the next generation high-quality products. You will work in local as well as global NPI projects for Chemistry, Hardware and Software products.
The QA Specialist is part of the project Core Team ensuring compliance during development by providing guidance with regards to design and development requirements. High communication and team working skills is therefore of importance.
As QA Specialist, you will provide valuable input to the development process as well as performing review and approval of design documentation. You will be part of design- and milestone reviews giving recommendations and make decisions. This requires that you as a person are pragmatic but still ensures compliance, you need to be patient and thorough and able to take decisions.
We also expect you to participate in initiatives to improve and optimize our internal processes as well as on an as needed basis take on other operational tasks within the QA department (for ex Risk Assessments, CAPA, Change Management and Root Cause Investigations).
As the QA Specialist, you are not only the expert on the design & development requirements, you are also a great business partner supporting with knowledge in our ISO9001 quality system.
For more information please contact Christine Wahlgren (QA Sr Site Leader) by phone: +46 18-612 04 05 / +46 70-620 57 01
Technical or chemical degree
Knowledge with quality systems based on ISO 9001, ISO 13485 or GMP
Fluency in English and Swedish as local language
Previous experience from similar roles
Knowledge in software development
Understanding of GAMP requirements
For us your personality is as important as your technical knowledge. You need to be able to work both independently and in a team as well as take decisions, were needed.
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