Senior Quality Assurance Engineer for Regulatory Compliance
15 hours ago
As a Senior Quality Assurance Engineer in our Global Quality Management Operations team, you will play a critical role in ensuring the quality and safety of our medical devices. Your primary responsibility will be to drive Post Market Surveillance with your business partners at Ambu, ensuring process compliance with regulatory requirements and facilitating timely performance of PMS plans and reports.
You will also contribute to overall improvement of the Quality System Performance within QA processes and participate in global quality fora to discuss proactive process improvements.
About AmbuAmbu A/S is a rapidly expanding company with 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.
Key Responsibilities- Driving Post Market Surveillance with business partners in Ambu: continuous improvement of the process, ensuring process compliance with regulatory requirements, and facilitating timely performance of PMS plans and reports.
- Improving the Quality System Performance within QA processes.
- Participating in global quality fora to discuss proactive process improvements.
To succeed in this position, you should have:
- A relevant academic background, such as BSc/MSc/Engineer or similar.
- At least 5 years' experience working in a quality organization within Medical Devices or the pharmaceutical industry.
- Demonstrated experience with Post Market Surveillance.
- Strong knowledge of relevant regulations for medical devices, e.g., ISO13485, EU MDR, MDSAP, UK MD, and relevant standards.
We offer:
- 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.
- Remuneration in line with the market and performance (Salary range EUR 60,000 - 80,000 per annum).
- Room for active personal and professional advancement.
- A flexible workplace with the opportunity to work from home for up to 2 days per week.
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