Quality Compliance Specialist, Global Operations Job Details | Ambu

Do you want to develop and manage quality and process related challenges in AMBUs Global Supply Chain. Do you have an eye for detail and understand the importance of working in a regulated environment? Do you thrive in juggling many stakeholders?

Ambu is 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 Chaín. 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 the Quality Handbooks (QHBs), CAPAs etc, while developing and maintaining documentation.

Key responsibilities
Your main responsibilities will include:

• Ensuring relevant updated QHBs are accessible and understood by all relevant personnel.
• Managing revisions and updates to the QHB in a controlled and documented manner.
• Assuring audit and inspection readiness and support NCRs, CAPAs, Deviations.
• Developing and maintaining position based QHB training relationship.
• Creating, managing and owning CAPAs, NCRs, DEVs, SCOs, and DCOs as needed, ensuring thorough investigation and effective corrective and preventive actions.
• Owning and managing the internal and external audit processes, including planning, execution, and follow-up in cooperation with LOB.

You will also:

• Drive and develop compliance structure
• E2E responsible Supply Chain QA projects in the role of project lead /key resource
• Develop, implement, and maintain Supply Chains Quality Handbook, ensuring it aligns with current regulatory requirements (e.g., ISO 13485).
• Implement best practices and transfer knowledge from QA to lines of business in Supply Chain
• Provide training and support.
• Provide guidance and support to Supply Chain teams on quality-related processes and procedures.
• Own and maintain all quality-related documentation pertaining to the Global Supply Chain.
• Manage document control for all GSC related documentation.
• Provide timely and accurate responses to inquiries and ensure clear communication between QA and GSC.
• Facilitate training to Supply Chain related QA processes.
• Update and maintain documentation across all functions in Supply Chain.
• Maintain accurate records of all quality events and ensure timely closure of actions.
• Act as the primary point of contact for the Supply Chain regarding quality assurance process questions.
• Act as a key link between the Quality Assurance department and Global Supply Chain
• Ensure alignment of quality initiatives across the organization.
• Represent GSC in QA meetings.
• Ensure compliance with audit requirements and implement corrective actions as needed.

Suggested candidate profile
Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you have:

• Bachelor's degree in a relevant scientific or engineering discipline (e.g., Biomedical Engineering, Quality Management).
• Minimum 3 years of experience in a Quality Assurance role within the medical device industry.
• Understanding of ISO 13485, and other relevant regulatory standards.
• 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.

Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.