BILJANA MIRCEVA
Maennedorf
Summary
Experienced, adaptive, and resourceful professional dedicated to advancing the organization's strategic direction and fostering a positive workplace culture, who inspires committed engagement amidst ever-changing environments through a results-driven approach.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Senior Quality Systems and Global LSO Manager
Tecan Schweiz AG
2023.04 - Current
- Enhanced the global training management process by simplifying the workflow with less administrative work
- Championed diversity and inclusion efforts within the training organization, resulting in an inclusive environment that fostered creativity and innovation among employees from various backgrounds.
- Led strategically aligned with top management change initiative to drive organizational transformation without compromising employee morale or productivity levels.
- Exceeded departmental goals by developing and executing strategic quality improvement plans and key performance metrics.
- Led successful CAPA program
- Optimized the document management service
- Contributed to successfully to passed MDSAP audit
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Increased customer satisfaction through adherence to quality standards and customer requirements.
- Conducted thorough enterprise risk management assessments to identify potential issues and develop appropriate mitigation strategies.
Quality Systems Manager
Tecan Schweiz AG
2014.06 - 2023.03
- Led the digitalization of document management project
- 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.
- Partnered with sales and marketing teams to ensure customer feedback was utilized for continuous improvement initiatives within the organization.
- Chaired quality 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 Inspection
- Improved communication channels between departments through routine CAPA review board meetings focused on addressing challenges related to maintaining high levels of product quality.
Quality Administrator
Tecan Schweiz AG
2012.01 - 2014.06
- Managed and archived quality documentation and participated in internal and external quality audits.
- Devised specifications for processes.
- 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.
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
- Conducted regular audits, identifying areas for improvement and implementing corrective actions promptly.
Various Marketing Roles
SBS Swiss Business School And Avanon
2007.10 - 2011.09
- Marketing campaigns support.
- Self-motivated, with a strong sense of personal responsibility.
- Worked effectively in fast-paced environments.
- Strengthened communication skills through regular interactions with others.
Education
Executive MBA in International Management -
SBS Swiss Business School
09.2022
Bachelor in Entrepreneurship -
Academy of Economics D.A. Tsenov
03.2005
Skills
- Leadership
- Change Management
- Communication
- Project Management
- Quality Management
- Employee Coaching and Mentoring
- Complex Problem-Solving
- Cross-Functional Teamwork
- Training and Development
- Process Improvement
- Digital Skills
- Business Administration
Languages
English
German
Macedonian
Bulgarian
Linkedin Profile
www.linkedin.com/in/bjanii
Certification
- CPTM - Certified Professional in Training Management
- Certificate in Project Management
- Certificate ISO 14971:2019
- Certificate MDR 2017/745
- Certificate IVDR 2017/746
- Certificate ISO 13485:2016
- Certificate ISO 9001:2015
- Certificate in Software Development according IEC 62304
- Certificate in Corrective and Preventive Action
Painting Artist
Immersed in the vibrant world of acrylic painting, I find boundless joy and fulfillment in every stroke of the brush. With each canvas, I embark on a journey of self-expression, translating emotions, experiences, and visions into vivid, tangible art. The versatility of acrylics allows me to experiment endlessly, from capturing the ethereal beauty of nature to exploring the depths of abstract concepts. Through my passion for acrylic painting, I uncover a profound sense of connection with both my inner self and the world around me, continuously inspired by the endless possibilities of color, texture, and form.
Timeline
Senior Quality Systems and Global LSO Manager
Tecan Schweiz AG
2023.04 - Current
Quality Systems Manager
Tecan Schweiz AG
2014.06 - 2023.03
Quality Administrator
Tecan Schweiz AG
2012.01 - 2014.06
Various Marketing Roles
SBS Swiss Business School And Avanon
2007.10 - 2011.09
Executive MBA in International Management -
SBS Swiss Business School
Bachelor in Entrepreneurship -
Academy of Economics D.A. Tsenov
- CPTM - Certified Professional in Training Management
- Certificate in Project Management
- Certificate ISO 14971:2019
- Certificate MDR 2017/745
- Certificate IVDR 2017/746
- Certificate ISO 13485:2016
- Certificate ISO 9001:2015
- Certificate in Software Development according IEC 62304
- Certificate in Corrective and Preventive Action
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