QUALIFICATIONS

Education: Bachelor’s Degree in a technical field such as Science or Engineering, or an equivalent combination of education and work experience.

Experience:

• ISO 13485 - certified in medical devices.
• Experience in medical devices or pharmaceuticals.
• Experience in quality assurance, internal auditing, quality compliance management, or related fields.

• Lead and support assigned internal, clinical, and supplier audits to ensure timely closure of audit cycles.
• Support audit readiness activities for external audits, including training staff and providing guidance in preparation for external audits.
• Support compliance gap management activities, such as compliance risk management.
• Identify risks to the division and propose resolutions to address compliance gaps.
• Strategize and prioritize compliance gaps and track them to closure.
• Provide guidance to SMEs in closing compliance gaps.
• Assist in the management of the near-miss program.
• Track regulations and industry standards revisions, evaluate their impact, and ensure compliance.
• Prepare, review, and investigate metrics data.
• Promote awareness and understanding of quality and compliance within the division. Provide training to increase compliance awareness.
• Participate in and manage compliance initiatives and other assigned projects.