At a Glance
- Tasks: Ensure AI-driven products meet top quality and compliance standards in a fast-paced environment.
- Company: Join an innovative tech company at the forefront of AI and healthcare.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Other info: Dynamic team with a focus on innovation and career advancement.
- Why this job: Make a real impact on healthcare through cutting-edge AI solutions.
- Qualifications: Experience in Quality Assurance and understanding of AI or software systems.
The predicted salary is between 50000 - 70000 £ per year.
We are supporting a rapidly growing, innovation-driven technology company operating at the intersection of artificial intelligence, healthcare, and data science. Their mission is to deliver cutting-edge AI-powered solutions that support decision-making, improve outcomes, and enable scalable, compliant deployment of advanced technologies across regulated environments.
We are seeking a highly motivated Senior Quality Assurance Specialist to join an expanding team. This role will play a critical part in ensuring that AI-driven products, systems, and processes meet the highest standards of quality, compliance, and regulatory integrity. You will work cross-functionally with product, engineering, data science, and regulatory teams, supporting the development and deployment of AI-enabled solutions in line with applicable quality standards. This position is ideal for someone who combines strong QA expertise with an understanding of software, data systems, or AI environments, and who thrives in a fast-paced, evolving organisation.
- Quality Management & Compliance
- Maintain and enhance the Quality Management System (QMS) in line with applicable standards.
- Ensure organisational compliance with internal quality policies and external regulatory requirements.
- Support quality strategy aligned with product and organisational growth.
- Audit & Inspection Readiness
- Lead and support internal and external audits, including regulatory inspections.
- Design, implement, and continuously improve quality processes, SOPs, and documentation frameworks.
- Support scalability of QA processes in a high-growth environment.
- Product & Development Quality Oversight
- Partner with engineering and data science teams to embed quality standards across the product lifecycle.
- Software development, data governance, and integrity.
- Risk Management
- Conduct and support risk assessments (e.g. FMEA, risk logs) related to products and processes.
Qualifications:
- Bachelor’s degree in a relevant field (e.g. Life Sciences, Engineering, Computer Science, or related).
- Significant experience in Quality Assurance within regulated environments (e.g. pharma, biotech, medtech, or digital health).
- Regulatory and compliance principles (GxP, data integrity, audit readiness).
- Experience supporting audits and inspections.
- Experience working with AI/ML systems, digital health platforms, or software products.
- Software development lifecycle (SDLC) knowledge.
- Validation practices for digital or AI-based products.
- Knowledge of emerging regulatory frameworks for AI (e.g. CQI, Six Sigma, Quality certifications).
Quality Specialist - Medical Devices employer: Cpl Life Sciences
Join a pioneering technology company at the forefront of AI and healthcare, where innovation meets quality assurance. As a Quality Specialist, you will thrive in a dynamic work culture that values collaboration and continuous improvement, offering ample opportunities for professional growth and development. With a commitment to excellence and compliance, this role not only supports cutting-edge solutions but also empowers you to make a meaningful impact in the medical devices sector.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Specialist - Medical Devices
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend meetups, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their mission and how your skills align with their goals. This will help you stand out and show that you're genuinely interested in what they do.
✨Tip Number 3
Practice common interview questions, especially those related to quality assurance and compliance. Be ready to share specific examples from your experience that demonstrate your expertise in regulated environments.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace Quality Specialist - Medical Devices
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Specialist role. Highlight your experience in QA within regulated environments and any relevant projects you've worked on, especially those involving AI or software development.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share specific examples of how you've maintained quality standards and supported audits in previous positions. Show us your passion for innovation in healthcare!
Showcase Your Skills:Don’t forget to highlight your skills in risk management and compliance. Mention any experience with regulatory frameworks or quality certifications that align with our mission at StudySmarter.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Quality Standards
Make sure you brush up on the relevant quality standards and regulatory requirements specific to the medical devices sector. Familiarise yourself with GxP principles and how they apply to AI-driven products, as this will show your understanding of the industry's compliance landscape.
✨Showcase Your Cross-Functional Experience
Be prepared to discuss your experience working with different teams, such as engineering and data science. Highlight specific examples where you've successfully collaborated to embed quality standards throughout the product lifecycle, as this role requires strong cross-functional teamwork.
✨Prepare for Risk Management Questions
Expect questions around risk assessments and management practices like FMEA. Have a few examples ready that demonstrate your ability to identify risks and implement effective mitigation strategies, especially in fast-paced environments.
✨Stay Updated on AI Regulations
Since the role involves AI-powered solutions, it's crucial to be aware of emerging regulatory frameworks for AI. Research recent developments and be ready to discuss how these might impact quality assurance practices in the medical device industry.
