For a leading company in the Software /AI Medical Device industry we are seeking a Quality Assurance Specialist. This role involves supporting the Quality Management System (QMS) across the organization, focusing on product maintenance, development, and growth. The Quality Assurance Specialist will handle document management, QMS training, complaint and CAPA management, under guidance.
- Manage and lead the document management process, including configuration management.
- Work cross-functionally to lead the complaint management process, including investigations, customer interactions, and reporting to management.
- Lead the CAPA management process, identifying root causes, and implementing remediations.
- Conduct QMS training and retraining to ensure compliance with US and International requirements.
- Assist in the evaluation and qualification of suppliers.
- Complete Quality System Audits (internal and external) to ensure compliance.
- Bachelor’s degree in a relevant field (or equivalent experience, i.e., Associate's Degree with 3 years of experience).
- Strong knowledge of FDA Quality System Regulations, including 21 CFR 11, and 21 CFR 820.
- Familiarity with EU Medical Device Regulation (MDR), ISO 13485, ISO 14971, and IEC 62034 is preferred.
- 2 – 4 years of experience in a regulated industry (FDA and Software as a Medical Device preferred).
- Experience participating in regulatory audits is a plus.
- Excellent written and oral communication skills.
- Requires ability to travel (~10% of the time), drive a vehicle, and use other forms of transportation.
- Unique opportunity to contribute to the regulatory success of innovative medical device products in a dynamic and challenging environment.
- Hybrid working from both Rotterdam or Amsterdam office
- Competitive market salary and interesting secondary benefits
Interested applicants are encouraged to apply immediately by sending their CV to Aimee Brenner at firstname.lastname@example.org.