Indigo is looking to hire
A motivated Lab Manager, to maintain, adapt and further develop the needed infrastructure, in line with the requirements of the technology under development as well as in compliance with governing quality standards (specifically, ISO13485:2016).
In continuous interaction with the R&D and the Quality Assurance team, your role will facilitate the grow of a compliant and state-of-the-art infrastructure with corresponding processes for the further development of healthcare solutions with Indigo’s products.
Your main tasks and responsibilities include:
- Develop, maintain and enforce infrastructure requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product.
- Maintaining and developing appropriate policies, processes and procedures for the R&D laboratory infrastructure to meet technology and safety requirements
- Training and educating all employees on operational, quality and safety procedures
- Plan, document & maintain requirements, as well as coordination of maintenance activities infrastructure and equipment
- Align and maintain coherence in all operational processes that relate to laboratory infrastructure, including (for example) the procedures to handle incoming and outgoing goods, as well as storage and stock management
- Co-create, support, and communicate laboratory initiatives and philosophies
- Serve as subject matter expert to guide others in the correct use of processes and infrastructure
- Plan and document arrangements to prevent contamination of the product or the infrastructure
- Participate in the selection process for new instruments
- Research new tests, technology, and instruments to meet infrastructure requirements
- Monitor, review and audit the work and work environment for continuous improvement
- Promote a culture of structure, organization, and continuous process improvement
- Communicate to supervisor any issues that could potentially impact the product’s safety and performance, the product’s reliability.
- Engage with technology development engineers to understand the processes and infrastructural needs for product development activities
- Always be audit ready and be able to deal with auditors and regulators
- Experience in management of infrastructure for medical device development under ISO13485:2016, or equivalent.
- Experience working in technology development environments with good hands-on technical skills
- Bachelor’s degree in chemical, biological, physical, or biomedical science or – engineering, or technical equivalent.
- Strong written and oral communication skills in English
- Ability to write clear and comprehensive documentation
- Structured mind, with solution-oriented thinking skills and attention to detail.
- Pragmatic, confident, hands-on with a strong positive ‘can-do’ attitude
- Independent judgment skills and action orientation for obtaining required results
- Experience in clean room management is a plus
- Experience in the US FDA Quality system: FDA CFR 21 Part 820 is a plus
What we offer
Together with Indigo’s team of experts, you will work on the development of the first invisible Continuous Glucose Monitor, which will improve the life of so many people living with Diabetes.
You will be part of a fast growing and very international team with plenty of development opportunities.
We offer a very competitive salary, freedom to work independently, a fun-loving and high-performing team and the opportunity to work on one of the defining technologies for the coming decade in diabetes management.
Join us today!
Send us your motivation letter and CV (HR@indigomed.com)
We look forward to hearing from you!