For our endclient in Eindhoven we are searching for a Quality Engineer Software
Do you want to accelerate the realization of the Internet of Things and the dramatic impact it will have on the economy, science, and society at large?
Do you want to help shape and define the future of healthcare by developing connected solutions that focus on impact & better health outcomes?
Can you take a pro-active yet pragmatic and incremental approach to ensure compliance with Quality Systems and regulations that govern product development activities within the department?
Do you have a holistic quality assurance strategy that comprises different quality assurance techniques in order to increase and prove product quality during all stages of product development?
Are you ready to embrace the challenge to combine agile development methods in regulatory environments?
Support and facilitate the department in enabling and assuring that medical regulated products are developed and produced in compliance with requirements from applicable standards (process focus)
Embed Quality & Regulatory requirements in the design and build processes for End to End software development (connected measuring devices, apps on smartphones, storage in clients cloud, and data analytics/visualization/insights generation)
Create the (project) quality plan and make sure it is being executed
Help to apply the QMS processes and procedures in the project
Support in applying requirements of applicable standards (ISO13485, ISO14971, IEC62304, IEC60601)
Are responsible for the product risk management plan and V&V-plan
Are responsible for requirements traceability, and monitor upon completion
Assist in experimental setup (compliance to relevant standards)
Prepare milestone reviews by collecting the status of all deliverables
Ensure proper approval of deliverables
Participate in risk assessments
Participate in review meetings
Review and approve Corrective Actions and Preventive Actions (CAPA)
Review and approve product change controls for quality and regulatory compliance impact and determine requirements for implementation
We are looking for someone with a…
Master’s degree with 2+ years of QA experience, Bachelor degree in a technical field with 4+ years’ experience in (networked) medical regulated product development
Preferably you are a Certified Quality Engineer (ASQ)
Relevant work experience in product software development with demonstrable focus on quality and acting as a quality engineer
Excellent understanding of medical device development and in driving quality and regulatory challenges regarding US and EU medical device regulations (i.e., 21 CFR 820, MDD)
Proven track record with development methodologies like Agile/Scrum/V-Model
Experience with working in 10+ person multidisciplinary teams
This role will appeal to you if you…
Enjoy working in cross-functional teams
Are curious, open and feel at home in an international environment
Have an affinity with innovative development projects and feel comfortable with relatively vague requirements
If you are interested, please respond with an up-to-date CV, hourly rate, availability and motivation letter.
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