Senior QA Specialist (12 months Contract) in Melbourne, Australia at Leica Biosystems

Date Posted: 11/6/2019

Job Snapshot

Job Description

Job ID: ADV001163

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

This is a professional position with responsibilities for elements of the site quality system in order to meet all applicable requirements for the medical device/IVD business. The Senior Quality Assurance Specialist is experienced in multiple areas of medical device quality assurance and is capable of applying that experience and in-depth knowledge to work independently with minimal guidance from management. May lead small projects with manageable risks and resource requirements.  Ability to solve complex problems affecting the quality system.  Shares information and experience across LBS and Danaher sites; may serve as representative on taskforces, councils or improvement initiatives.

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:
    • Customer Complaint and Adverse Event Investigations
    • Support the organization, planning, hosting, and close-out of audits.
    • Lead tasks in support of non-conformances, CAPA, process validation, record management, document controls and training.  
    • Review and approve batch records.  Guide QA Officers on the approval of non-routine batch records.
    • Collect and track quality system data and metrics for routine reporting as part of Daily Management and take appropriate countermeasures as required.
    • Conduct tasks in support of Design QA and risk management.
  • 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.
  • 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

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.
  • Must have requisite training or certification in medical device Quality Assurance through on-the-job training, seminars, training.  
  • Extensive knowledge of medical device quality systems including but not limited to 21 CFR 820 and ISO 13485.   Working knowledge of medical device design controls and risk management preferred.
  • Experience conducting and hosting external quality system audits desirable.

Competencies

  • Ability to apply practical QA experience and knowledge to multiple areas of quality assurance. 
  • Ability to identify, analyze and mitigate risk (e.g. product, material, compliance, supply)
  • Ability to work independently and collaboratively within a team.
  • Strong organizational skills.  Ability to multitask.
  • Strong communication skills. Ability to explain difficult or sensitive information. Works to build consensus.  
  • High level of initiative, self-motivation and energy.
  • Strong commitment to quality and compliance. Organized and detail-oriented.
  • Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports. 
  • Customer focused.
  • High level of integrity. Operates with transparency and is trusted.  Demonstrates humility and self-awareness. 

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, 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.