Wat ga je doen?
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
Wat vragen wij?
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
Wat bieden wij?
In addition to working on a ground breaking 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