Altran is looking for an experienced Quality Engineer Medical Devices. Do you believe that technology can make a big impact on business and society?
Are you driven by getting the best out of yourself and your team? Do you know like no other what Quality Assurance should look like?
Are you still interested? Please continue reading.
We are looking for an innovation maker with in-depth knowledge of quality processes as well as a broad experience with medical device product development.
You will be involved in the most exciting projects, focused on improving the product and process quality for medical devices.
What you will do
Participate in creating solutions to complex problems for our clients in the Life Science sector and ensure an efficient regulatory compliance for sustainable access.
Implement or ensure a compliant Quality System that is adapted to the business needs and site specifications, and keep it up-
to-date with regulatory upgrades all times;
Support of the whole life cycle for medical devices (21 CFR 820, ISO 13485 &14971);
Involved in the most exciting projects in which you will expand your expertise by working closely with our clients to really make innovation matter.
Getting involved with safety, regulatory compliance and data (cyber)security issues;
What you will bring
Bachelor or Master degree in (Bio)Medical Engineering, Electrical Engineering, or equivalent.
Proven background in a Manufacturing / Production or Product development environment;
Experience working with quality and reliability tools and templates, e.g. Minitab, JMP, Reliasoft, FMEA, FTA, HAZOP;
Perform by a unique end-to-end approach combining technology, usage and verification & validation;
Familiar with relevant regulations and standards (e.g. EU MDD, FDA, ISO 13485, IEC 62302);
Good knowledge of management structure (ISO certified) providing continuous and effective support and training programmes, pooling and sharing knowledge and experience, as well as industry-
specific best practices and benchmarks is an absolute plus;
Strong verbal and writing skills in English;
knowledge of Quality Assurance and also a broad knowledge of Quality Systems (Quality Audit and Quality Systems optimization), Operational Quality Assurance, Quality Control, Qualification & Validation, Quality coaching & training and Quality & compliance management tools.
Personal skills :
A team player, enthusiastic, client and goal oriented, ambitious and ready to take on a challenge;
You can adapt easily in new environments and have developed organizational sensitivity;
You have a creative mind and like to develop yourself more in skills and knowledge by training and coaching and working on innovative, technically challenging and complex projects;
You can see the bigger picture, have a strong analytical mind and approach challenges from a practical standpoint;
You are flexible and can communicate on different levels.
What we offer you
A permanent contract with a competitive salary
A variable bonus plan
A lease car or mobility budget
Flexible secondary conditions
Extensive training programs through our Altran Academy
A yearly personal innovations budget
Altran is the global leader in R&D and engineering consulting. In more than 20 countries we work side by side with our clients in the creation and development of new products and services.
Innovation is our guiding principle, with which we lead in a world where change is a constant factor. In The Netherlands we bring the most complex and innovative projects of our customers to life too.
More than 800 consultants use their expertise every day to improve the performance of our customers. We can proudly say that we are the go-
to partner in the field of technical innovation and process improvement.