Novartis Logo

Novartis

Design Quality Assurance Engineer

Job Posted 23 Days Ago Reposted 23 Days Ago
Be an Early Applicant
Cambridge, Cambridgeshire, England
Mid level
Cambridge, Cambridgeshire, England
Mid level
The Design Quality Assurance Engineer supports medical device and combination product development by preparing design documentation, ensuring compliance with quality standards, guiding project teams on design assurance, and participating in design reviews. The role includes reporting technical complaints and advocating for continuous improvement.
The summary above was generated by AI

Job Description Summary

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.


 

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:

Your responsibilities include, but not limited to:

  • 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.

  • Interface with Quality Assurance functions to ensure compliance with company QMS and international standards and regulations.

  • Guide and/or support project teams through design assurance and compliance activities and ensure best practices.

  • Participate in and/or lead design reviews.

  • 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:

Essential Requirements:

  • Masters, PhD, or university degree in the field of engineering, Quality, life sciences, or other relevant subject

  • Good working knowledge of medical device and drug-device combination product development processes including design verification.

  • Proven track record (3+ years) as part of a medical device development team within a pharmaceutical, medical devices, and/or combination products setting.

  • Experience of working within the ISO13485 medical devices quality framework and in-depth knowledge of GMP, EU, and FDA regulatory requirements.

  • A clear thinker, who can work independently and as part of a matrix team structure.

  • Ability to take ownership of initiatives, deliver results and strive for continuous improvement.

  • Results orientated, enthusiastic, and driven by excellence.

  • 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.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here:  Sandoz Talentpool (novartis.com)

#Sandoz


 

Skills Desired

Design, FDA Regulatory Requirements, Medical Devices, Product Design, Product Development

Top Skills

Design
Fda Regulatory Requirements
Medical Devices
Product Design
Product Development

Novartis London, England Office

The WestWorks, White City Place, London, United Kingdom, W12 7FQ

Similar Jobs

4 Days Ago
Hybrid
Farnborough, Rushmoor, Hampshire, England, GBR
Mid level
Mid level
Cloud • Fintech • Machine Learning • Analytics • Financial Services
As a Senior Associate Quality Application Engineer, you will participate in agile teams to develop and test features, manage risks, and contribute to system design. Your responsibility will include building automated tests and mentoring new engineers while ensuring the quality of applications in production.
Top Skills: AnsibleContainersCukeJenkinsJmeterPublic Cloud
18 Days Ago
Gloucester, Gloucestershire, England, GBR
Senior level
Senior level
Aerospace • Energy
The Lead Design Quality Assurance Engineer will develop and execute an audit plan to ensure compliance with regulatory standards, improve quality processes, manage audit findings, and support quality reporting. This role involves collaboration with teams to uphold quality standards, influence improvement projects, and provide technical guidance to stakeholders.
Top Skills: As9100Audit ManagementDesign ProcessesEngineeringIso9001Part21 RegulationsQuality AssuranceQuality Management System
23 Days Ago
Hybrid
London, Greater London, England, GBR
Junior
Junior
Artificial Intelligence • Fintech • Other • Automation
The Design Verification Engineer at Hudson River Trading is responsible for creating testbenches, writing verification plans, debugging RTL issues, managing test suites, and developing tools in a fast-paced environment focused on hardware verification for trading technologies.
Top Skills: AsicC++CocotbFpgaLinuxPythonSystemverilogUvmVerilator

What you need to know about the London Tech Scene

London isn't just a hub for established businesses; it's also a nursery for innovation. Boasting one of the most recognized fintech ecosystems in Europe, attracting billions in investments each year, London's success has made it a go-to destination for startups looking to make their mark. Top U.K. companies like Hoptin, Moneybox and Marshmallow have already made the city their base — yet fintech is just the beginning. From healthtech to renewable energy to cybersecurity and beyond, the city's startups are breaking new ground across a range of industries.
By clicking Apply you agree to share your profile information with the hiring company.

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account