JOB SUMMARY:

We are seeking a highly motivated and experienced Quality Assurance specialist to join our dynamic team. The ideal candidate will be responsible for maintaining a robust Quality Management System while driving continuous improvement across the functions in Global Supply Chain. This role will be pivotal in ensuring compliance with relevant regulatory standards and fostering a culture of quality within our organization. The primary focus will be on managing and developing the Quality Handbooks (QHBs), DEVs, SCO´s CAPAs and at the same time be go to for GSC in terms of Compliance related questions.

QUALIFICATIONS:

• Minimum 3 years of experience in a Quality Assurance role within the medical device industry.
• Understanding of ISO 13485, and other relevant regulatory standards.
• Bachelor’s degree in a relevant scientific or engineering discipline.
• Proven experience in developing and managing Quality Management Systems.
• Experience with QMS methodologies and their application.
• Excellent communication, interpersonal, and problem-solving skills.
• Strong attention to detail and ability to manage multiple priorities.
• Strong business acumen and ability to transform operational solutions to relevant documentation.

• Create, manage and own CAPAs, NCRs, DEVs, SCOs, and DCOs as needed, ensuring thorough investigation and effective corrective and preventive actions.
• Ensure relevant updated QHBs are accessible and understood by all relevant personnel.
• Manage revisions and updates QHBs.
• Assure audit and inspection readiness and support NCRs, CAPAs, DEVs.
• Develop and maintain position based QHB training.
• Participate in change management projects and representing the QA process.
• Agile Superuser.