Quality Assurance Officer (Laboratory Medical Devices)

Internal Audit SupportAssist in conducting internal audits for IMS compliance.Prepare audit checklists and maintain records of findings and corrective actions.Ensure timely closure of nonconformities and CAPA documentation.Documentation PreparationReview and maintain IMS documentation (Quality Manual, SOPs, registers).IMS Surveillance ReadinessCoordinate activities for external surveillance audits related to IMS.Compile and organize compliance evidence for auditors.Liaise with cross-functional teams to ensure audit readiness.Training & AwarenessConduct periodic training sessions for staff on IMS requirements, documentation practices, and audit readiness.Promote quality culture and ensure employees understand compliance obligations.

Educational BackgroundBachelor’s Degree in Quality Assurance, Business Administration, Since, or related field.Relevant certifications (e.g., ISO 9001 Lead Auditor, Six Sigma) preferred.ExperienceMinimum 3 years of experience in internal auditing, quality assurance, or compliance roles.SkillsStrong knowledge of ISO standards (e.g., ISO 9001, ISO 14001).Proficient in audit techniques and methodologies.Excellent documentation skills, including familiarity with SOPs and quality manuals.Ability to prepare comprehensive audit checklists and compliance reports.Communication SkillsStrong verbal and written communication skills.Interpersonal SkillsStrong organizational and project management skills.Ability to work collaboratively with cross-functional teams.Excellent problem-solving abilities and attention to detail.