Requirements
Bachelor's degree in Science, Pharmacy, Engineering, or a related field.2–5 years of Quality Assurance experience in a medical devices or pharmaceutical manufacturing company.Strong knowledge of ISO 13485, GMP, CAPA, Internal Audits, Document Control, and Risk Management.Proficiency in Microsoft Excel and Microsoft Office applications.Good command of written and spoken English.Strong analytical, communication, and problem-solving skills.Ability to work effectively in a fast-paced manufacturing environment.
Description
We are seeking a qualified Quality Assurance Specialist to join our Quality team in a medical devices manufacturing company. The successful candidate will be responsible for maintaining and improving the Quality Management System (QMS), ensuring compliance with ISO 13485, GMP, and regulatory requirements while supporting continuous improvement initiatives.Key Responsibilities:Implement and maintain the Quality Management System (QMS) in accordance with ISO 13485 and company procedures.Prepare, review, and control quality documents, including SOPs, work instructions, and quality records.Conduct internal audits and participate in external audits and regulatory inspections.Manage CAPA, Non-Conformance Reports (NCR), Deviations, and Change Control activities.Perform Root Cause Analysis (RCA) and ensure the effectiveness of corrective and preventive actions.Monitor compliance with GMP requirements across manufacturing processes.Review batch records and quality documentation to ensure accuracy and completeness.Support risk management activities and continuous improvement projects.Collaborate with Production, QC, Engineering, and Regulatory Affairs to resolve quality issues.Prepare quality reports, analyze trends, and recommend improvement opportunities.Train employees on quality procedures and ensure compliance with company policies.