Principal Specialist, Quality Assurance (Design)
Principal Specialist, Quality Assurance (Design)

Principal Specialist, Quality Assurance (Design)

North East Full-Time 36000 - 60000 Β£ / year (est.) No home office possible
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At a Glance

  • 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 Β£ per year.

Overview

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Responsibilities

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Additional Information

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Principal Specialist, Quality Assurance (Design) employer: Leica Biosystems

At Leica Biosystems, we are dedicated to advancing cancer diagnostics and improving lives, making us an exceptional employer for those passionate about life sciences and biotechnology. Our collaborative culture fosters belonging and innovation, providing employees with opportunities for professional growth while working on impactful projects that save lives. Located in Newcastle-upon-Tyne, our team enjoys a supportive environment where every contribution matters, and we are committed to continuous improvement through the Danaher Business System.
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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)

Design Control Leadership
Knowledge of Design/Development Practices
IVD Medical Device New Product Development
Regulatory Compliance Knowledge
Familiarity with 21 CFR 820
Understanding of ISO 13485
Experience with ISO 14971
MDSAP Knowledge
Quality Systems Management
Project Management Skills
Supplier Auditing Experience
Strong Communication Skills
Problem-Solving Skills
Ability to Work Independently
Team Leadership Experience

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.

Principal Specialist, Quality Assurance (Design)
Leica Biosystems
Location: North East
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  • Principal Specialist, Quality Assurance (Design)

    North East
    Full-Time
    36000 - 60000 Β£ / year (est.)
  • L

    Leica Biosystems

    1000-5000
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