City: Ballerup
State:
Country: Denmark
Business Area: Quality Assurance
Department: Global Quality Management Operations & IT Compliance
Employment Type: Full-time
Job Title: Supplier Quality Management (SQM) – (Senior) Quality Assurance Engineer
Are you passionate about quality and compliance within the Medical Device industry? Do you want to be a part of a global organization with high professional standards and a great working environment? Then we have an exciting new job opportunity that may be your next career move.
Apply today and join us as (Senior) Quality Assurance Engineer in Global Quality Management Operations out of our HQ in Ballerup, Denmark.
Key responsibilities
In this role, you will be part of a great team consisting of 11+ talented QM professionals. Your main task will be to drive our Supplier Quality Management processes together with your SQM colleagues in Global Quality Management Operations. Supplier auditing, developing and optimizing the SQM processes within your team’s area of responsibility is part of the role.
Supporting our strategic journey in QM Operations we are looking for a strong candidate to guide and give input to improve our Supplier Quality Management processes together with our stakeholders in Global Quality Management - in corporate and local functions and stakeholders in Line of Business – primarily Global Procurement.
Your main responsibilities will include:
- Responsible for driving Supplier Quality Control pertaining to Global Quality Management
- Supplier Quality Agreements
- Supplier approvals
- Supplier reevaluations
- Supplier monitoring
- Supplier sourcing projects
- Execution of Supplier Audits as Lead auditor and/or co-auditor according to audit plan
- Assist in providing relevant data for Management Review and Quality reporting in collaboration with your colleagues
- Close collaboration with Global Procurement and Global Supply Chain on supplier quality issues including input to and review supplier information and KPIs.
- Participate in global quality fora to discuss proactive process improvements and supplier quality issues
- Continuously monitor the processes with SQM area of responsibility for compliance and improvements
Other tasks that potentially be included or be involved in:
- Support other processes and tasks within QM Operations
Suggested candidate profile
Skills and experiences can be gained in several ways, and we understand that the best fit for the role can have relevant experience and competences from diverse areas. You are however likely to succeed in this position if you:
- Have a relevant academic background, BSc / MSc/ Engineer
- Have at least 2-8 years’ experience working in a quality organization within Medical Devices
- Carry demonstrated experience working with Supplier Quality Management processes
- Have ISO13485 Auditor/Lead auditor training
- Competences into IT supplier auditing and monitoring could be an advantage (e.g. knowledge within Information Security – ISO27001, NIS2)
- Have strong knowledge of relevant regulations for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MD and relevant standards.
- Have passion for quality and focus on QM business partnering with the organization.
As a person, you are outgoing, open to learning, and you can work both in groups and independently. You have good collaboration and communication skills and are experienced at prioritizing and working focused to meet required timelines. For all key responsibilities you are able to balance regulatory and business requirements.
Ambu is a global company, English is therefore our corporate language, which requires proficiency in professional English.
Ambu promise.
- The chance to actively help shape a paradigm shift in the healthcare market
- An exciting job with innovative and groundbreaking medical device products
- A pleasant working atmosphere where the customer is the focus of our work
- A collegial, friendly and dynamic working environment in a constantly growing company
- Participation in an energetic team with short communication channels
- Remuneration in line with the market and performance.
- Room for active personal and professional advancement
- The possibility to work from home for up to two days per week
How to apply
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis.
If you have any questions about the position, you can contact Head of Global Quality Management Operations and IT Compliance Niels-Jørgen Svarrer, at nisv@ambu.com
Your application will be treated with confidentiality.
About Ambu
Ambu has been bringing solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.
For more information, please visit ambu.com or follow us on LinkedIn.
About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.
For more information, please visit ambu.com or follow us on LinkedIn.