Vacature - Jouw nieuwe functie
Quality Specialist
QTC are partnered with a leading Dutch medical device scale-up focused primarily in the opthalmic sector searching for a Quality Specialist to join their team based out of Den Haag. Due to increased demand, the organisation have ambitious growth plans over the coming year to increase from their current headcount of 30 FTE.
Details
Medical Devices
Quality/RA
Den Haag - Netherlands
40 uur per week
leer ons kennen
Jouw consultant
Over jouw rol
Zo maak jij het verschil
The Quality Specialist function will work closely with the Quality Manager to maintain and enhance the Quality Management System as the organisation transition from ISO 9001 to ISO 13485. You'll play a vital role in driving continuous improvement initiatives and ensuring regulatory compliance (MDR).
Responsibilities:
Overseeing the CAPA process and root cause analysis.
Driving risk management initiatives and change controls.
Supporting internal and external audits.
Handling supplier qualifications and customer complaints.
Wat nodig is
Wat jij mee brengt
Requirements:
- Minimum HBO/BSc degree in Life Science or related field.
- Quality management knowledge, preferably within a MDR/ISO 13485 environment.
- Knowledge of FDA and GMP is a plus.
- English fluency, Dutch is a plus.
- Willingness to travel for supplier audits.
Wat wij bieden
Jouw voordelen
Offer:
- Competitive salary with company-wide bonus scheme
- Hybrid work pattern with option to work 32 hours
- International and dynamic team with a brand new office
- Team outings and wellness facilities
- Personal Development Plan
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