Design Quality Assurance Engineer

Sandoz International GmbH; Cambridge; Hybrid; GBP 40,000 - 80,000; Full time

Job summary

An established industry player is seeking a Design Assurance Engineer to support the development of innovative medical devices. This role offers a unique opportunity to contribute to the creation of sustainable biosimilar and generic medicines that impact millions of patients worldwide. As part of a collaborative team, you will prepare essential design documentation, ensure compliance with international regulations, and drive best practices in product development. Join a forward-thinking company that values diversity and personal growth, and play a key role in shaping the future of healthcare while enjoying a flexible work environment and competitive benefits.

Benefits

Competitive salary

Annual bonus

Pension scheme

Share scheme

Health insurance

24 days annual leave

Flexible working arrangements

Employee recognition scheme

Learning and development opportunities

Qualifications

• 3+ years experience in medical device development within a pharmaceutical setting.
• Strong knowledge of design verification and regulatory requirements.

Responsibilities

• Prepare design documentation for medical devices and combination products.
• Interface with Quality Assurance to ensure compliance with standards.
• Lead design reviews and report technical complaints promptly.

Skills

Design Assurance

Quality Management Systems (QMS)

Regulatory Compliance

Medical Device Development

Continuous Improvement

Team Collaboration

Problem Solving

Communication Skills

Education

Masters or PhD in Engineering

University Degree in Life Sciences

Tools

ISO13485

GMP

FDA Regulations

Job description

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!

The Design Assurance Engineer provides support for medical device and combination product developments.

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. Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt.

What you’ll bring to the role:

1. Masters, PhD, or university degree in the field of engineering, Quality, 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 of working within the ISO13485 medical devices quality framework and in-depth knowledge of GMP, EU, and FDA regulatory requirements.
5. A clear thinker, who can work independently and as part of a matrix team structure.
6. Ability to take ownership of initiatives, deliver results and strive for continuous improvement.
7. Results orientated, enthusiastic, and driven by excellence.
8. 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.