Leading and supporting investigations and projects to address root causes of nonconformances
Participating in rebranding activities at the plant
Ensuring compliance with applicable standards and regulations
Being a critical team member in service execution
Working with supplier quality and vendors to ensure conforming input material is delivered to the manufacturing lines

Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, Quality Management, or a related scientific field
Preferred 2–3 years of experience in Quality Assurance / Quality Systems within the pharmaceutical or medical device industry
Strong knowledge ISO 13485 /EU MDR/ FDA
Experience working with Quality Management Systems (Deviation Management, CAPA, Change Control, Document Control, Audits, Training)
Experience with risk management tools (e.g., FMEA)
Knowledge of validation, qualification, and data integrity principles
Experience in supporting regulatory inspections and customer quality audits
Knowledge of GMP
Ability to lead small quality improvement projects
Excellent analytical thinking, problem-solving abilities, and attention to detail
Strong communication skills and ability to collaborate with cross-functional teams (QA, QC, Production, Engineering, Validation)
Fluent English (written and spoken)
Experience in using the SAP system is welcome
Current, valid Driver’s License would be beneficial

Quality Engineer

Key skills