Senior QA Officer – Design Quality (12-14 month Fixed Term) in Newcastle upon Tyne, United Kingdom at Leica Biosystems

Date Posted: 8/14/2019

Job Snapshot

Job Description

Job ID: ADV001115

About Us

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.  Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com  for more information.


Description

About the role:
This role is primarily responsible for QA input into new product development projects, specifically premarket quality, design assurance and R&D quality. The candidate should be experienced in workload prioritisation and have the ability to work on multiple projects at the same time. 

Major Responsibilities:
  • Responsible for planning, organizing and conducting duties related to assigned element of the site quality system. May include one or more of the following areas
  • Quality Systems
    • Establish and maintain quality system to meet all applicable requirements for medical device/IVD business, e.g. 21 CFR 820 and ISO 13485
    • Audits
    • Non conformances
    • CAPA
    • Validation
    • Batch release
    • Training
    • Quality agreements
    • Record management and document control
  • Supplier quality
    • Work with procurement on supplier quality standards, supplier quality agreements, metrics
    • Supplier audits
    • Ensure quality of incoming materials
  • Premarket QA / Design Assurance / R&D Quality
    • QA representative for Design Controls and Risk Management for new product development projects and device change initiatives
    • Support design quality assurance for cross-site project
  • Utilize knowledge and experience to identify, solve and document problems and risks within the quality system.
  • Serve as a resource and mentor to colleagues with less experience, including QA Officers.
  • Use Danaher Business System (DBS) tools on a regular basis to continually improve the QA function.
  • Work closely with QRA management in developing quality objectives.  
  • Establish and maintain strong relationships with internal and external stakeholders.
  • Maintain working knowledge of relevant regulations and quality system requirements that affect the business.
  • Other duties as assigned by management.

Job Requirements



Qualifications

An ideal candidate would be experienced in:

  • Quality Management Systems, in particular Non-Conformances, Change Controls, Concessions, Risk Management and Design Control.
  • R&D projects including compilation of Design History Files and Design Reviews.
  • Project management, experience of Visual project Management (VPM) would be beneficial.
  • A track record of achievement and an ability to ensure project needs are met on a sustained and in a timely manner.
  • Previous experience of regulatory inspections (e.g. FDA, BSi) is preferred.

In addition, the successful candidate will also be able to demonstrate that they are committed, resilient, results focused and driven to achieve in a constantly changing environment. They are a true team player, strong communicator and are able to build and sustain strong working relationships. They are open-minded and adopt a positive ‘can do’ approach to all tasks with a view to drive for continuous improvement.


Required Skills/Experience/Education:

  • Bachelor’s degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance, or 
  • Graduate degree in science, medical or technical field and experience with increasing responsibility in medical device Quality Assurance.
  • Experience in the IVD field preferred experience very beneficial
  • Must have requisite training or certification in medical device Quality Assurance through on-the-job training, seminars, training.   Relevant certifications preferred.
  • Depending on assigned area:
    • Experience conducting and hosting quality system audits.
    • Extensive knowledge of medical device quality systems including but not limited to 21 CFR 820 and ISO 13485.   Strong working knowledge of medical device design controls.
    • Experience in medical device Design Controls and Risk Management
    • Experience in supplier quality, manufacturing, supplier risk management, design transfer processes

Competencies:

  • Ability to apply practical QA experience and knowledge to one or more area(s) of quality assurance.  
  • Ability to identify, analyze and mitigate risk (e.g. product, material, compliance, supply)
  • Ability to work independently 
  • Strong organizational skills.  Ability to multitask
  • Strong communication skills. Ability to explain difficult or sensitive information. Works to build consensus.   
  • Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports.  
  • High level of integrity

Travel % of Travel, include approximate overnight stays per week:

  • Travel expectations within this role will vary based on assignment (Low for Quality Systems <10%, Moderate for Supply Quality and Design Quality <30%)

Location:  

  • This Position is in LBS Newcastle UK. 

Reporting to:

  • This role will report to the Senior QRA Manager. 

To Apply:
Leica Biosystems is committed to attracting and retaining the most highly qualified candidates available. We firmly believe that our employees drive the success of the company. With success in mind as the ultimate goal, we strive to create and provide an environment that offers challenging, stimulating and financially rewarding opportunities.  As a Leica Biosystems employee you will be consistently challenged to deliver your best. 
If you are ready for this challenge, submit your resume for consideration.  http://www.leicabiosystems.com/about/careers/
Be sure to follow Leica Biosystems on LinkedIn!


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.