Senior QA Officer
Senior QA Officer
Ready for your next step in Quality Assurance? I am looking for a Senior QA Officer for an international medical devices company. You will be based in their location in the Netherlands (Gelderland). In this role, you will assist the QA Manager for the Dutch operations of the QMS. You will be part of the QA team, which contains 3 QA officers and the QA Manager.
These will be your tasks and responsibilities:
- Managing the Quality Management System (ISO13485:2016, MDD/MDR and the FDA 21 CFR part 820);
- Non conformity management (CAPA's, customer complaint management, SCAR management);
- Focussing on improvements by performing root cause analysis and trend analysis regarding non conformity management
- Conducting internal audits and assisting in external audits;
- Providing support in cross functional QA projects as a member or a leader (depending on the project);
- Ensuring that adequate input is delivered for management reviews and monthly reports.
You will need to have the following skills:
- Minimum of 3 years' experience in the medical devices industry
- Knowledge of and experience with the ISO13485:2016, MDD/MDR and 21 CFR part 820;
- You have a good understanding of the English language, both written and oral;
- You have good communication skills;
- You are capable to work in a large, international organisation;
- You are result-driven and able to work independently.
- Fulltime position (part-time is possible as well with a minimum of 32 hours a week
- Competitive salary
- Bonus of 5%
- Travel allowance
- International career opportunities
Interested in this role?
Are you the Senior QA Officer I am looking for? Please don't hesitate to contact Joey Wielkens on the phone number 020-5221577 or send an e-mail to j.wielkens @ realstaffing.com. You may also contact me if you have questions about this role.