The Design Assurance Engineer ensures project compliance to relevant regulations and to external and internal standards for design control activities and project documents.
Your Key Responsibilities:
1. Prepare medical device and drug/device combination product design and development documentation and compilation of Design History Files and/or Technical Files in collaboration with multi-disciplinary project teams.
2. Interface with Quality Assurance functions to ensure compliance with company QMS and international standards and regulations.
3. Guide and/or support project teams through design assurance and compliance activities and ensure best practices.
4. Participate in and/or lead design reviews.
5. Prepare medical device and drug/device combination product risk management documentation.
What you’ll bring to the role:
1. Masters, PhD, or university degree in the field of engineering, quality management, life sciences, or other relevant subject.
2. Good working knowledge of medical device and drug-device combination product development processes including design verification.
3. Proven track record (3+ years) as part of a medical device development team within a pharmaceutical, medical devices, and/or combination products setting.
4. Experience working within the ISO13485 medical devices quality framework and in-depth knowledge of GMP, EU, and FDA regulatory requirements.
5. Experience working with ISO14971 risk management for medical devices.
6. Clear thinker, who can work independently and as part of a matrix team structure.
7. Ability to take ownership of initiatives, deliver results and strive for continuous improvement.
8. Results-orientated, enthusiastic, and driven by excellence.
9. Excellent command of English (verbal and written).
You’ll receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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