Senior QA Engineer
- Groningen
- BSc
- 32 - 40 hours
- 4000 - 5600 per month
- 8614
Senior QA Engineer
- Groningen
- BSc
- 32 - 40 hours
- 4000 - 5600 per month
- 8614
In this role as Senior QA Engineer, you play a key role in safeguarding and continuously improving quality within a regulated medical device and pharmaceutical environment. Does this spark your interest? Apply now!
What are you going to do?
As a Senior QA Engineer, you are responsible for assuring and improving quality throughout the entire product life cycle. You work closely with Engineering, R&D and Quality Operations and translate regulatory requirements and quality standards into practical and robust processes. In this role, you combine in-depth QA expertise with an advisory and coordinating responsibility. Your key responsibilities include:
- Managing and maintaining the Quality Management System (QMS), including document control and change control.
- Ensuring compliance with GMP, MDR/MDD, ISO 13485, ISO 14971 and QSR CFR 820, and translating regulatory requirements into practical QA solutions.
- Coordinating and handling non-conformities, deviations and CAPAs, including root cause analyses and improvement actions.
- Providing QA guidance within engineering projects, including validation of equipment and processes.
- Supporting R&D projects by performing risk analyses, preparing risk management documentation and participating in design reviews.
- Advising, reviewing and (approving) changes to products, processes and production activities.
- Analyzing quality and production data to identify trends and drive continuous improvement.
What do we ask?
For the position of Senior QA Engineer, we are looking for candidates who match the following profile:
- Bachelor’s or Master’s degree in a relevant field (such as Pharmacy or Biotechnology).
- At least 4 years of relevant QA experience within the medical device or pharmaceutical industry.
- Thorough knowledge of quality standards such as GMP, MDD/MDR, ISO 13485 and ISO 14971.
- Experience with validation of technical systems and processes.
- Excellent command of the English language and a good command of Dutch.
- Strong communication skills, accurate and quality-driven, with a practical mindset and the ability to translate regulations into daily practice.
(32 - 40 hours/week)
What do we have to offer?
- A 12-month employment contract via CheckMark.
- A full-time position, with 32 hours per week negotiable.
- A largely on-site role (minimum 4 days per week).
- A salary indication between €4,000 and €5,600 gross per month based on full-time employment, depending on relevant work experience.
Where will you be working?
Our client in Groningen is part of a global organization and focuses on the manufacturing of specialized medical devices. This role is positioned within the QA Engineering group, which is responsible for ensuring quality assurance within product and process development projects.
"Found a new challenge through CheckMark. Great conversations, solid preparation, and supportive guidance from Na Rae. Informal yet professional, highly recommended!"
Questions? Contact us!
Jurjen Wilschut
Senior Recruiter & New Business
Apply for Senior QA Engineer
Complete the form and take the next step in your career! Our recruiters will contact you shortly to discuss your application and guide you further through the process.
Questions? Contact us!
Jurjen Wilschut
Senior Recruiter & New Business