At a Glance
- Tasks: Own and improve quality systems for a groundbreaking cancer detection test.
- Company: Join a dynamic startup focused on innovative medical diagnostics.
- Benefits: Be part of a small, values-driven team with opportunities for personal growth.
- Other info: Fast-paced environment where your ideas and expertise truly matter.
- Why this job: Make a real impact in healthcare while developing your career in quality management.
- Qualifications: 5+ years in quality roles within regulated environments, ISO knowledge essential.
The predicted salary is between 50000 - 65000 £ per year.
Xgenera is a diagnostic company developing a multi-cancer early detection test and preparing to establish a UK diagnostic service laboratory. We are looking for a hands-on Quality Manager to own and develop our quality systems as we move from R&D and clinical trial execution toward commercial diagnostic testing. This is a foundational role as an individual contributor.
You will maintain and improve our ISO 13485-aligned QMS while building the systems required for an ISO 15189 medical laboratory. You will work directly with the CEO and technical team to create pragmatic, audit-ready processes that support speed, quality, and future accreditation. You will be expected to write documents, create and improve processes, run quality activities, train the team, prepare for audits, and help make quality part of how the company works every day. This position offers the chance to build quality functions from the ground up with scope to become the long-term quality leader of the company.
Responsibilities:- Own and improve the existing QMS.
- Work with quality and regulatory consultants to build and implement ISO 15189 processes.
- Support ISO 13485 certification readiness.
- Establish internal audit processes and prepare the company for external audits, certification, and future UKAS accreditation.
- Support development of SOPs, document control, CAPA, change control, deviation/nonconformance handling, supplier qualification, and training records.
- Work closely with technical staff to ensure quality by design principles whilst ensuring compliance is practical.
Qualifications:
- 5+ years in a Quality role in medical devices, diagnostics, clinical labs or another regulated life science environment.
- Demonstrable understanding of ISO 15189.
- Practical, risk-based approach to quality.
- Strong interpersonal skills and ability to work directly with the CEO and technical team to build and improve systems from the ground up.
- Willingness to work in a fast-moving startup environment and an ability to be dynamic and prioritise work accordingly.
- Good understanding of ISO 13485.
- Experience in a startup, scale-up, or small regulated company.
- Familiarity with molecular workflows, PCR, sample handling, contamination control, or clinical testing environments.
Why work at Xgenera?
At Xgenera, you’ll be part of a team doing something truly unique and exciting: developing and bringing to market a multi-cancer early detection test with the potential to deliver huge societal benefit. As a start-up, we offer the chance to get involved in varied, meaningful work where your ideas, energy and expertise can have a real impact. You’ll join a small team of less than 10 that are ambitious, collaborative and deeply values-led, with integrity, innovation, transparency, compassion and a commitment to shaping a better future at the heart of everything we do. We care about our employees as people, and we’re building an environment where everyone can contribute, grow and be proud of the work they’re doing.
Quality Manager — Medical Devices & Diagnostic Lab Startup in Southampton employer: Xgenera
At Xgenera, we pride ourselves on being an exceptional employer, offering a unique opportunity to shape the future of cancer detection in a collaborative and values-driven environment. Our small, dedicated team fosters a culture of innovation and integrity, where your contributions are valued and can lead to significant societal impact. With a focus on employee growth and meaningful work, you will have the chance to build quality systems from the ground up while enjoying the support of a passionate team committed to making a difference.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Manager — Medical Devices & Diagnostic Lab Startup in Southampton
✨Tip Number 1
Network like a pro! Reach out to people in the medical devices and diagnostics field. Attend industry events, join relevant online forums, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Show off your skills! Prepare a portfolio that highlights your experience with ISO standards and quality management systems. Bring it along to interviews or share it during networking chats. This will help you stand out and demonstrate your hands-on approach to quality management.
✨Tip Number 3
Be proactive! Don’t just wait for job postings to appear. Research companies like Xgenera and reach out directly. Express your interest in their mission and how your skills can contribute to their goals. A personal touch can make all the difference!
✨Tip Number 4
Prepare for interviews by understanding the company’s values and culture. At Xgenera, they value integrity and innovation, so think about how your experiences align with these principles. Be ready to discuss how you can help build quality functions from the ground up!
We think you need these skills to ace Quality Manager — Medical Devices & Diagnostic Lab Startup in Southampton
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Manager role. Highlight your experience with ISO standards and any relevant projects you've worked on. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management in medical devices and how you can contribute to our mission at Xgenera. Keep it engaging and personal.
Showcase Your Skills:Don’t just list your skills; demonstrate them! Include specific examples of how you've improved quality systems or handled audits in the past. We love seeing practical, real-world applications of your expertise.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity at Xgenera. We can’t wait to hear from you!
How to prepare for a job interview at Xgenera
✨Know Your Standards
Make sure you have a solid understanding of ISO 13485 and ISO 15189. Brush up on the key principles and how they apply to quality management in medical devices and diagnostics. Being able to discuss these standards confidently will show that you're serious about the role.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've successfully implemented quality systems or processes. Highlight any experience you have in a startup environment, as this will resonate well with the company’s dynamic culture.
✨Be Ready for Practical Scenarios
Expect to be asked about real-world scenarios related to quality management. Think through how you would handle situations like nonconformance or CAPA processes. This will demonstrate your practical, risk-based approach to quality.
✨Connect with the Team
Since you'll be working closely with the CEO and technical team, show your interpersonal skills during the interview. Be prepared to discuss how you can collaborate effectively and contribute to building a quality culture within the company.
