Biljana Mirceva Email & Phone Number

Switzerland

• By offering guidance and mentorship, I've cultivated a culture of professional advancement within the team. Witnessing the tangible progress and success of mentees has solidified my commitment to fostering individual growth and building trust-based relationships.• Enhanced operational efficiencies by pinpointing bottlenecks within our training management program and implementing tailored solutions strategically. This initiative resulted in a significant 25% reduction in administrative steps, streamlining processes and driving notable improvements.• Strategically led a change initiative in alignment with top management objectives, driving organizational transformation while safeguarding employee morale and maintaining productivity levels.• Drove unprecedented achievement by elevating KPI outcomes through the strategic development and meticulous execution of quality improvement plans.• Spearheaded and executed a highly successful CAPA (Corrective and Preventive Action) program, delivering impactful results and driving continuous improvement across the organization.• Played a pivotal role in ensuring the successful completion of the MDSAP audit, demonstrating expertise and dedication in navigating complex regulatory requirements and contributing to the attainment of our audit objectives.• Implemented comprehensive enterprise risk management assessments, identifying potential issues and crafting mitigation strategies to safeguard against risks and ensure sustained organizational resilience.

Männedorf, Zürich, Schweiz

• Catalyzed and orchestrated a transformative initiative in document management digitization, resulting in a notable 50% enhancement in process speed.• Mentored and encouraged employees to strive for excellence while fostering professional growth.• Advised management of quality audit non-compliance issues to facilitate improved audit compliance rates.• Led ISO 13485 and ISO 9001 successful certification project through diligent preparation, documentation, and adherence to international standards of quality management.• Collaborated closely with our sales and marketing teams, harnessing the invaluable insights from customer feedback to fuel a dynamic array of continuous improvement initiatives across the organization, ultimately amplifying customer satisfaction to new heights.• Chaired management review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.• Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.• Contributed to successful FDA Inspections.• Improved communication channels between departments through routine CAPA review board meetings focused on addressing challenges related to maintaining high levels of product quality.• Incorporated the regulatory requirements of the IVDR 2017/746 into the Quality Management System.

• Tracked quality issues with external customers, suppliers, and internal plant operations.• Organization and planning of external and internal audits.• Streamlined documentation processes for increased efficiency in the quality department.• Conducted regular audits, identifying areas for improvement and implementing corrective actions promptly.• Managed quality documentation maintenance and participated in internal and external quality audits.

Marketing-Events and Projects CoordinationWebsite MaintenanceAccounting Support

International Student Program Management Organised Trade-shows Customer Database Management Design of Marketing ContentOnline Marketing and Telesales

Executive Mba, International Management

Bachelor'S Degree, Entrepreneurship

Education record