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- Tasks: Lead quality assurance for innovative cancer diagnostic products and improve development processes.
- Company: Join Leica Biosystems, a leader in life sciences dedicated to advancing cancer diagnostics.
- Benefits: Enjoy a collaborative culture, opportunities for growth, and the chance to make a real impact.
- Why this job: Be part of a passionate team transforming lives through cutting-edge medical technology.
- Qualifications: Bachelor's degree in a relevant field and experience in medical device quality assurance required.
- Other info: On-site role in Newcastle-upon-Tyne with up to 20% travel.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Principal Specialist, Quality Assurance (Design)
Join to apply for the Principal Specialist, Quality Assurance (Design) role at Leica Biosystems
Principal Specialist, Quality Assurance (Design)
4 days ago Be among the first 25 applicants
Join to apply for the Principal Specialist, Quality Assurance (Design) role at Leica Biosystems
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System which makes everything possible.
The Principal Specialist, Quality Assurance (Design) for Leica Biosystems is responsible for delivering and sustaining advance staining reagents and diagnostic assays into the Clinical Market.
This position reports to the Director, Quality Assurance & Regulatory Compliance and is part of the Quality Assurance and Regulatory Compliance Department located in Newcastle-upon-Tyne and will be an on-site position.
In this role, you will have the opportunity to:
- Work on site projects to support the progression of the most viable commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management (PLCM).
- Provide Design Control leadership across or within function, working with other LBS and Danaher sites.
- Work independently and with project team members to develop and improve processes to reduce variability and increase robustness throughout the development and product lifecycle for multiple projects.
- May lead functional teams or projects with moderate resource requirements, risk, and/or complexity
- Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications.
The essential requirements of the job include:
- Strong working knowledge of Design Controls & Design/Development practices for regulated products.
- Extensive experience in IVD medical device new product development and design controls.
- Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, ISO 14971 & MDSAP.
- Quality leadership experience with IVD medical devices.
- Bachelor’s degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance
Travel, Motor Vehicle Record & Physical/Environment Requirements:
- Ability to travel – up to 20% travel
It would be a plus if you also possess previous experience in:
- Experienced in delivering higher classification medical devices and/or companion diagnostic products to market.
- Supplier Auditing and/or Quality Assurance.
- Experience with the MDSAP Programme
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Full-time
Job function
-
Job function
Project Management and Information Technology
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Principal Specialist, Quality Assurance (Design) employer: Leica Biosystems
Contact Detail:
Leica Biosystems Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Specialist, Quality Assurance (Design)
✨Tip Number 1
Familiarise yourself with the specific quality assurance standards and regulations relevant to IVD medical devices, such as ISO 13485 and 21 CFR 820. This knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 2
Network with professionals in the life sciences and diagnostics sectors, especially those who have experience with Leica Biosystems or similar companies. Engaging in conversations can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and advancements in cancer diagnostics and biotechnology. Being knowledgeable about current developments can set you apart during discussions and show your passion for the industry.
✨Tip Number 4
Prepare to discuss your previous experiences with design controls and product lifecycle management in detail. Be ready to share specific examples of how you've improved processes or led teams in past roles, as this will highlight your suitability for the position.
We think you need these skills to ace Principal Specialist, Quality Assurance (Design)
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Principal Specialist, Quality Assurance (Design) role. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience with Design Controls and IVD medical device development. Use specific examples that demonstrate your leadership in quality assurance and regulatory compliance.
Showcase Your Skills: Clearly outline your skills related to quality systems, such as knowledge of ISO standards and experience with FDA submissions. Make sure to connect these skills to how they can benefit Leica Biosystems.
Craft a Compelling Cover Letter: Write a personalised cover letter that reflects your passion for life sciences and diagnostics. Mention why you want to work at Leica Biosystems and how your values align with their mission of advancing cancer diagnostics.
How to prepare for a job interview at Leica Biosystems
✨Understand the Company’s Mission
Before your interview, make sure you understand Leica Biosystems' mission of 'Advancing Cancer Diagnostics, Improving Lives'. This will help you align your answers with their core values and demonstrate your commitment to making a difference in life sciences.
✨Showcase Your Design Control Knowledge
As a Principal Specialist in Quality Assurance, you'll need to highlight your strong working knowledge of Design Controls. Be prepared to discuss specific examples from your past experience where you successfully implemented design control practices in regulated environments.
✨Prepare for Regulatory Compliance Questions
Given the role's focus on regulatory submissions, brush up on your knowledge of international IVD medical device quality systems like 21 CFR 820 and ISO 13485. Expect questions about how you've navigated these regulations in previous roles.
✨Demonstrate Leadership Experience
The position may involve leading functional teams or projects, so be ready to share instances where you've taken on leadership roles. Discuss how you managed resources, mitigated risks, and drove project success in a collaborative environment.
