Medical Device Auditor
Pfizer Inc. is a research-based company, known as the number one global biopharmaceutical giant. They apply science and global resources to bring therapies to people that extend and significantly improve their lives through the discovery, development and manufacturing of healthcare products. The global portfolio includes medicines and vaccines, as well as many of the world’s best-known consumer healthcare products.
Due to the fast growth of the Production Plant and transition into the Medical Device market, we are looking for Engineers with a Medical Device background in Packaging.
We are looking for an internal auditor with focus area Medical Device and Combination Products (MDCP).
Main tasks and responsibilities:
• You execute internal audits versus the MDCP requirements
• You coordinate gap assessments versus the existing legislation, Pfizer Quality Standards and observations of previous inspections in other Pfizer sites.
• You coordinate the preparation of external audits and inspections.
• You are the main point of contact for all MDCP questions and expectations.
• You have a master’s degree in a scientific field (bio-engineer, pharmacist, civil engineer, biology, chemistry, …).
• You have a minimum of 5 years of experience in a medical device audit environment.
• You have thorough understanding of regulations of medical devices or combination products.
• You can analyze processes with attention for detail.
• You possess excellent social skills and are a team player.
• You are a strong communicator in both English and Dutch.
• You can partner with the production colleagues to look for workable and compliant solutions.
• You are punctual with an eye for detail.
• You have excellent priority setting, planning and organizing skills.