Act as the key Quality Assurance partner for Finished Goods Operations (FGO).
Support lot review, product release, and quality processes to ensure compliance with regulatory requirements.
Work closely with cross-functional teams.
Perform lot review and product release activities for Finished Goods.
Review and approve quality documentation.
Coordinate with cross-functional teams to ensure consistent execution.
Support nonconformance investigations and CAPA activities.
Provide Quality Assurance support to resolve issues impacting compliance.
Monitor and support quality metrics related to Finished Goods.
Support internal and external audits related to Finished Goods Operations.
Drive continuous improvement initiatives.
Requirements
Bachelor’s degree in Engineering.
Minimum 2 years of experience as Quality Engineer within highly regulated environments (e.g., medical devices, pharmaceuticals, automotive, aerospace).
Experience reviewing documentation and supporting quality or operational processes.
Knowledge of regulated environments and quality systems (e.g., GMP or equivalent).
Fluent English proficiency (written and verbal).
Proficiency in Microsoft Office (Excel, Word, PowerPoint).