Quality Engineer

Opdrachtgever

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

At least 4 years of proven experience in engineering in the (bio)pharmaceutical or medical devices industry.
Minimum of 2 years experience with NC/CAPA management, GMP training and document/record management.
Excellent verbal and written communication skills in English.
Capable of engaging effectively with internal and external stakeholders up to the departmental management level.
Experience with risk management tools (e.g., FMEA, HACCP) and root cause analysis techniques (e.g., 5-Whys, Kepler-Tregoe, Ishikawa).
Ability to present and defend departmental quality assurance practices and findings.
Strong analytical thinking skills, with the ability to handle complexity, ask insightful questions, utilize data effectively, identify gaps, and develop creative solutions.
Proficiency in computer applications such as MS Office, Tableau, and eDMS.

Collaborate with cross-functional teams (Operations, QC, QA) to analyze and resolve quality issues.
Lead investigations into non-conformances and CAPAs, including risk assessments, root cause analysis, and the successful implementation of CAPA.
Support GMP training compliance, preparing updates and assist management in content review and periodic assessments.
Serve as the primary contact for internal and external audits/inspections, coordinating support from the department.
Develop and maintain weekly and monthly quality metrics related to GMP training, document reviews, non-conformance, and CAPA tracking. Investigate and remediate identified issues.
Act as the record coordinator for the department, advising on record management, including archiving physical records and ensuring data integrity.
Promote quality awareness within the department by sharing relevant topics to reduce recurring issues.
Work independently with minimal supervision to meet tight deadlines while ensuring compliance with all company policies and procedures.