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- Tasks: Lead quality assurance for innovative diagnostic solutions in a collaborative environment.
- Company: Join Danaher, a leader in life sciences and biotechnology, dedicated to advancing cancer diagnostics.
- Benefits: Enjoy a dynamic workplace with opportunities for growth and up to 20% travel.
- Why this job: Make a real impact on lives while working on cutting-edge medical devices and therapies.
- Qualifications: Bachelor's degree in a relevant field and experience in medical device quality assurance required.
- Other info: This is an on-site role based in Newcastle-upon-Tyne.
The predicted salary is between 36000 - 60000 £ per year.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? And by harnessing Danaher\’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Our mission of \”Advancing Cancer Diagnostics, Improving Lives\” is the driving force behind everything we do. 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. 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. 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. 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 Experienced in delivering higher classification medical devices and/or companion diagnostic products to market. Supplier Auditing and/or Quality Assurance. 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.
Specialist, Quality Assurance employer: Leica Biosystems
Contact Detail:
Leica Biosystems Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Specialist, Quality Assurance
✨Tip Number 1
Familiarise yourself with the specific quality assurance standards and regulations mentioned in the job description, such as ISO 13485 and 21 CFR 820. This knowledge will not only help you understand the role better but also demonstrate your commitment to the field during interviews.
✨Tip Number 2
Network with professionals in the life sciences and diagnostics sectors, especially those who have experience with IVD medical devices. Engaging with industry experts can provide valuable insights and potentially lead to referrals that could enhance your application.
✨Tip Number 3
Prepare to discuss your experience with Design Controls and how you've applied them in past roles. Be ready to share specific examples of projects where you improved processes or reduced variability, as this aligns closely with the responsibilities of the position.
✨Tip Number 4
Research StudySmarter and our mission in advancing cancer diagnostics. Understanding our values and how they align with your own will help you articulate why you're a great fit for the team during any discussions or interviews.
We think you need these skills to ace Specialist, Quality Assurance
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Specialist, Quality Assurance position. Make sure you understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in quality assurance, particularly in IVD medical devices. Mention specific projects or roles where you demonstrated design control leadership and compliance with regulatory standards.
Showcase Your Skills: Clearly outline your skills related to quality systems, such as knowledge of ISO 13485 and 21 CFR 820. Use examples to illustrate how you've applied these skills in previous roles, especially in new product development.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the mission of advancing cancer diagnostics. Express your passion for making a difference in life sciences and how your expertise aligns with the company's goals.
How to prepare for a job interview at Leica Biosystems
✨Understand the Company Mission
Familiarise yourself with Danaher's mission of 'Advancing Cancer Diagnostics, Improving Lives'. Be prepared to discuss how your skills and experiences align with this mission and how you can contribute to their goals.
✨Showcase Your Quality Assurance Expertise
Highlight your extensive knowledge of IVD medical device quality systems and design controls. Be ready to provide specific examples of how you've successfully implemented these practices in previous roles.
✨Prepare for Technical Questions
Expect technical questions related to regulatory submissions, such as FDA 510(k)s and PMAs. Brush up on relevant regulations like 21 CFR 820 and ISO 13485 to demonstrate your expertise.
✨Demonstrate Leadership Skills
Since the role may involve leading functional teams, prepare to discuss your leadership experiences. Share examples of how you've guided teams through complex projects and improved processes in a collaborative environment.
