Post Market Surveillance (PMS), Quality Assurance Engineer
Are you excited about safety, performance, 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 job opportunity that may be your next career move.
Apply today and join us as PMS, Quality Assurance Engineer in Global Quality Management Operations out of our HQ in Ballerup, Denmark – and take our Post Market Surveillance process to the next level.
Key responsibilities
In this role, you will be part of a great team consisting of 10 talented Quality Management professionals. Together, you will ensure device safety and performance, quality and regulatory compliance of Ambu products and processes across the organization. You will be part of the Global Quality Management Operation team, which main responsibility is to continuously monitor compliance via CA/PA, NCR, Supplier Quality Management, Intelligence reporting, PMS, Complaint handling etc.
Supporting our strategic journey in Quality Management Operations we are looking for a strong candidate to drive and further develop and improve our Post Market Surveillance process together with our PMS Process owner and stakeholders in Global Quality Management.
Your primary responsibilities will include:
- Responsible for driving Post Market Surveillance activities and deliverables (PMS plans and PMSR/ PSURs) timely with stakeholders in Ambu
- Contribute to continuous improvement of the PMS process in collaboration with the Process Owner and colleagues in the department
- Contribute to ensuring the PMS process is in compliance with regulatory requirements
- Continuous improvement of the Quality System Performance within QA Processes
- Participate in global quality fora to discuss proactive process improvement
Other tasks that you could potentially participate in, within QM Operations, depending on your previous experience and interests, could be:
- Customer Complaint case monitoring in collaboration with our Complaint process owner
- Key Performance Indicator (KPI) reporting for Management Review and other relevant quality reporting – in areas of PMS and Customer Complaints.
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, such as BSc / MSc / Engineer
- Have at least 2-5 years’ experience working within Medical Devices
- Carry demonstrated experience within Post Market Surveillance of Medical Device
- Have strong knowledge of relevant standards and regulations applicable for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MDR
- Have a passion for device safety, performance and quality, and focus on Quality Management business partnering within the organization
- Ambu is a global company, English is therefore our corporate language, which requires proficiency in professional English.
You're someone who enjoys learning and growing, and you’re comfortable working both independently and with others. You communicate clearly, collaborate well, and know how to stay focused and organized to meet deadlines. You’re also skilled at balancing regulatory requirements with business needs.
Most importantly, you won't be doing it alone , a supportive and collaborative team is ready to welcome you, share knowledge, and help you thrive from day one. We’d love to hear from you!
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
About Ambu
Ambu has been bringing their 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.
Your application will be treated with confidentiality.
For more information, please visit www.ambu.com or follow us on LinkedIn.