Quality Assurance Officer (Laboratory Medical Devices)

Your tasks

Internal Audit Support

• Assist 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 Preparation Review and maintain IMS documentation (Quality Manual, SOPs, registers).

IMS Surveillance Readiness

• Coordinate 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 & Awareness

• Conduct periodic training sessions for staff on IMS requirements, documentation practices, and audit readiness.
• Promote quality culture and ensure employees understand compliance obligations.

Requirements

Educational Background

• Bachelor’s Degree in Quality Assurance, Business Administration, Since, or related field.
• Relevant certifications (e.g., ISO 9001 Lead Auditor, Six Sigma) preferred.

• Minimum 3 years of experience in internal auditing, quality assurance, or compliance roles.

• Strong 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 Skills

• Strong verbal and written communication skills.

Interpersonal Skills

• Strong organizational and project management skills.
• Ability to work collaboratively with cross-functional teams.
• Excellent problem-solving abilities and attention to detail.