Quality Assurance Officer in Melbourne, Australia at Leica Biosystems

Date Posted: 9/15/2018

Job Snapshot

Job Description

Job ID: ADV000960

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

The primary focus of this role is to support quality assurance activities which include, but are not limited to, customer complaint handling, document control and batch release.

Responsibilities include:

  • Evaluation and investigation of customer complaints.
  • Maintenance of document control procedures and processes change orders in a timely manner with a high level of accuracy.
  • Archiving of documentation to ensure traceability and accessibility.
  • Review and authorise batch records (device history records) before products are released for distribution.
  • Maintain the training records system.
  • Assist with the co-ordination of the internal audit program.
  • Identify continuous improvement opportunities for the Quality Management System.

Job Requirements



Qualifications

To be considered for this role you must be able to demonstrate the following skills, experience and attributes:

  • Previous quality assurance experience in the medical device industry.
  • Conversant with the application of US FDA 21 CFR part 820 and ISO 13485.
  • Excellent written and verbal communication skills with the ability to target communications to the audience.
  • A collaborative and flexible approach.
  • High ethical standards.
  • Ability to handle multiple tasks/ projects and manage priorities accordingly.
  • Formal internal audit training desirable.
  • Degree in science or engineering related field.

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!

To all recruitment agencies: Leica does not accept agency resumes. Please do not forward resumes to our jobs alias, Leica employees or any other company location. Leica is not responsible for any fees related to unsolicited resumes.



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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 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.