Innovations are just ideas to be made
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? Then join our team of innovation makers in the Netherlands as a Consultant Quality Assurance.
Life Sciences is an ambitious, growing and successful domain within the Quality & Validation department of Altran Netherlands. This department is responsible for clients in Industry, High Tech, Food & Beverage, Chemicals and the Life Sciences (Biotech, Pharmaceuticals, Medical Devices) sectors. Our motivation is to successfully help our clients with solutions to their problems.
We are looking for an innovation maker with in-depth 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. 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 pharma (GLP, GCP, GCLP & GMP) and medical devices (21 CFR 820, ISO 13485 &14971). You will be involved in the most exciting projects in which you will expand your expertise by working closely with our clients to really make innovation matter.
As a consultant you?
- Perform regulatory inspection preparation & remediation
- Advice on supplier audits
- Work on backlog deviation
- Provide Lean Quality Control
- Provide Quality Efficiency by design
What do you bring?
- Bachelor or University 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
- Be involved in safety, regulatory compliance and data (cyber)security issues
- 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 Dutch and English
Who are you?
- You are 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 do we offer?
- A permanent contract with a competitive salary
- Profit sharing and a variable bonus plan
- A company car or mobility budget
- Extensive internal training programs
As global leader in innovation and high-tech engineering consulting, we work side by side with our clients in the creation and development of new products and services. We are on the cutting edge of technology and have established ourselves as the go-to partner for technical innovation and process improvement. Altran is proud to be the leader in its field.