Senior QA Specialist

2 weeks ago

Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.

Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

We are looking for a Senior QA Specialist to join our RAQA team, you’ll support our Newcastle facility in the UK to deliver

and sustain advance staining reagents and diagnostic assays in the clinical market. This role will oversee multiple project deliverables, as well as, provide review and guidance for risk management, verification and validation activities related to the development projects and the sustainment of documentation under IVDR.

**In this role, you’ll**:

- QA expert and representative for Design Control processes.
- Provide expertise in Design Quality Assurance for cross site projects and investigations.
- To facilitate Pre-Market Approvals for higher classification devices.
- Advise and support R&D and Design Quality Assurance in relevant regulatory requirements.
- Support Pre-Inspection Approval Readiness.
- Facilitate the release of Class II/Class III devices.
- Define and progress evidentiary requirements to meet targeted commercial claims and align with internal partners and stakeholders on study designs.
- Align with external partners and stakeholders on study designs, submissions etc., and participate in relevant meetings.
- Communicate and negotiate with global regulatory agencies to meet business goals and regulatory milestones for product commercialization.
- Keep informed of new and evolving regulatory intelligence and maintain working knowledge of relevant regulations, guidance, requirements and competitive products that affect the business; provide interpretation and education to internal and external stakeholders
- Responsible for planning, organizing and conducting duties related to Design Assurance.
- Participate in cross-functional teams at various phases of the development cycle as the Design Assurance representative.
- Work independently and with project team members to develop design control deliverables including quality plans, design controls deliverables, test methods, and Design History Files.
- Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications.
- 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.
- To support the technical teams in the leadership of post release changes; assessment of the planning, verification and validation of the change, ensuring the delivery to the business is within budget and on schedule
- Serve as a resource and mentor to colleagues with less experience.
- Acting as part of a team, or as a project lead, if required, to provide supervisory support and mentoring for a small team.
- Ensure that DBS learning’s and tools are actively employed to minimise waste and maximise efficiency at all times.
- To manage multiple stakeholders throughout the business to ensure they are informed and consulted as appropriate
- Maintain working knowledge of relevant regulations and quality system requirements that affect the business.

**What you’ll need to do the job**:

- Bachelor’s degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance.
- Strong working knowledge of Design Controls & Design/Development practices for regulated products.
- Extensive experience in IVD medical device new product development and design controls.
- IVDR knowledge and experience a distinct advantage.
- Extensive knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, ISO 14971 & MDSAP.

**Interested? Join the Leica Bio Systems Team**

At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arran

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