Senior Quality Engineer

About ViCentra

ViCentra is an innovative medical device company based in Utrecht, The Netherlands. ViCentra focuses on the research and development, manufacturing and commercialization of a ground-breaking device for the management of diabetes. Kaleido, one of world’s smallest and lightest insulin pump system available, is designed to help people with diabetes live life on their own terms:

"For us, super accurate insulin delivery and improved control are non-negotiables, but discretion, simplicity and choice is our way of helping you live life in your own way".

With CE mark, in-house software development and manufacturing, ViCentra is setting its sights on expanding insulin pump usage by appealing to both first time and experienced insulin pump users in France, Germany and the Netherlands. At the same time, we are preparing for FDA approval expansion into additional territories and establishing partnerships in digitalization and connectivity.

Funded by the venture capitalists LSP, INKEF, Invest-NL, Partners in Equity, and Health Innovations, ViCentra currently employs over 130 people from over 30 different nationalities.

The position

As a Senior Quality Engineer, you will be monitoring and improving the quality of our operational processes and outputs, working together with key stakeholders to implement quality measures ensuring processes and product(s) consistently meet established quality standards. The Senior Quality Engineer is part of the NPI (New Product/Process Introduction) department, which is part of the overall Quality & Regulatory Affairs department. The NPI team is supporting projects in the (Manufacturing) organization.

Main Responsibilities include but are not limited to:

• Working closely together with Manufacturing teams, other Quality and Regulatory Affairs employees and R&D employees, to develop and implement controls and improvements
• Collaborate with suppliers and CMO’s regarding (process) qualification activities
• Creating, reviewing and approving (process/ test method) validation and other documentation e.g. Documents related to the manufacturing and Quality Control
• Supporting and guiding the execution of (process) validations, test method validations and associated tests to be performed in close collaboration with other related/relevant disciplines
• Involvement in/ leading activities like measuring equipment verification/ validation against the respective requirements and specifications
• Review and approving specifications to ensure materials and components consistency and fulfilment of product performance needs and develop and implement inspection processes, test methods and quality plans for NPI projects
• Participating in risk management sessions
• Developing and implementing internal quality standards and methods to improve or enhance quality system processes
• Monitoring and analyzing quality performance
• Identifying quality process bottlenecks and suggest actions for improvement
• Supporting and leading projects for process improvement activities
• Ensure documentation is up to the required standard, delivered on time and within required specification, raising CAPA’s and Non Conformances (NCR’s) when required.
• Support/ execute investigations with root cause analysis, monitoring the effectiveness of corrective actions and preventive actions (Non conformances, CAPA’s)
• Support internal, supplier and external audits
• Develop and give Quality related training to organization

The ideal candidate to join our team should have:

To be successful in this role, you are a natural problem solver with strong analytical skills and a pro-active, hands-on mentality. You have a drive for quality and results with a clear focus on customer safety and continuous improvement. You are a team player, who can build lasting relationships with colleagues across departments and disciplines. Able to work under pressure, managing several tasks and projects at once poses no problem for you.

Qualifications & Experience

• Bachelor’s degree in Quality/ Mechanical/ Biomedical engineering/ health sciences or equivalent experience
• Minimum 5 years proven experience in Quality Engineering
• Excellent knowledge of quality control principles
• Good knowledge of validation, test method validation/ gage R&R and statistical techniques
• Excellent knowledge of ISO 13485, MDR and 21 CFR 820

Abilities

• Ability to organize and prioritize tasks
• Excellent time-management and organizational skills.
• Pragmatic, pro-active and entrepreneurial with the ability to work independently in a rapidly changing environment
• Strong problem solving and analysis skills.
• Strong admin and IT skills, particularly Microsoft Office
• Fluent written and spoken English. Dutch language is not required.
• Good communication skills
• Exceptional attention to detail

It’s a bonus if you also have:

• Experience in a start-up/ scale-up company
• Cleanroom environment experience
• Knowledge of sterilization processes (Gamma and EtO)
• Minitab experience

What we offer

In addition to working on a groundbreaking new product, you’ll be working in a small, friendly and highly motivated team; all ideas are welcomed and great work is rewarded. We’re also offering:

• Competitive salary + additional 8% holiday pay (paid annually)
• Competitive relocation package and assistance (as applicable)
• Assistance for the preferential 30% tax ruling application if applicable
• 25 days’ holiday per year (pro rata) + up to 13 ADV (time for time) days + 8 optional purchase days
• Defined benefit pension + disability insurance
• Full time (40 hours per week) 8 hours per day to be worked anytime between 07:00 to 19:00 Monday to Friday
• Contribution towards commuting costs (as applicable)
• A work environment where you can develop your skills, learn from the best and be rewarded for your imagination
• Free, on-site parking
• Discount on gym membership
• Informal dress code
• Social events
• Meaningful work with the opportunity to make a difference

Even More!

Working in Utrecht you will be working in one of The Netherlands oldest cities with a beautiful medieval centre arranged around canals. Recently voted the most vibrant city in the country (with the largest University in The Netherlands) it is the fourth largest city in the country. It is situated in the centre of the country 48km south of Amsterdam (27 minutes by train) and as such is within easy travel of a number of cities and sights. Moreover, we have a work hard/ play hard approach and believe in creating a fun, exciting work environment so ping pong breaks and team social events/ outings are usual. The free coffee and snacks help too!

Apply today

**We will start interviewing successful candidates without delay, therefore please submit your CV as soon as possible. If we like what we see we will contact you, if we don’t contact you within 4 weeks we’ve probably proceeded with other candidates but don’t lose heart as we might reach out to you if we have a different role or project we think might be a match**

If you've got any queries feel free to call +31 (0) 88 250 2900.

ViCentra is an equal opportunities employer and welcomes applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age. Due to the international nature of the Company applications are only accepted in English and candidates must also have the right to work in the Netherlands.

Agencies: Please note ViCentra is committed to sourcing candidates directly and as such we do not accept speculative CV’s from agencies. We do however work with an approved list of preferred suppliers but in line with our Preferred Supplier List we only pay agency fees where we have a signed agreement in place and a position has formally been placed with the agency by a member of the HR team. We do not pay fees where speculative and unsolicited CV’s are submitted to ViCentra or ViCentra employees. Where this is not observed ViCentra reserves the right to contact these candidates directly and initiate discussions without payment of any agency fee.