Quality Engineer - Medical Device in Vista, California at Leica Biosystems

Date Posted: 10/30/2019

Job Snapshot

Job Description

Job ID: PAT000589

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.

Leica Biosystems Imaging, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check. 

Be sure to follow Leica Biosystems on LinkedIn!


Grow your career while working on our world leading products!

The primary role of the Quality Engineer is to provide Quality Engineering support for software and hardware development projects. This includes providing specific project deliverables, as well as, providing review and guidance for verification and validation activities related to the development projects. In addition, the Quality Engineer will work with management and technical staff in the manufacturing function in the performance of root cause failure analysis, identification and implementation of corrective and preventive actions to preclude recurrence of identified issues. 

Major Responsibilities:
  • Participate in cross-functional teams at various phases of the development cycle as the Quality Engineering and Quality Systems representative. Work independently and with project team members to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and Device History Records. Assist with the development of project verification and validation activities.
  • Participate in the development and maintenance of product risk and hazard analysis and management for multiple projects in accordance with ISO 14971.
  • Identify manufacturing and development constraints. Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to preclude recurrence. 
  • Develop and Implement Test and Inspection processes for Incoming Materials, Work In-Process and Finished Devices, including all necessary validation and qualification activities. 
  • Work independently and with project team members to develop and improve product and processes to reduce variability and increase robustness throughout the development cycle for multiple projects. 
  • Prepare regular performance reports for Quality Management Systems, Operations, and project development. Maintain associated databases and design reports to reflect management input and changing organizational needs. 
  • Assist in the performance and documentation of internal and external audits in accordance with internal and supplier auditing schedules.  Respond to audit findings by proposing and implementing necessary corrective actions.  
  • Responsible for reviewing and verifying non-conforming materials and initiating and following up on associated corrective actions as required. 
  • Meet company and departmental goals in the continuous improvement of all products, services and processes. 
  • Perform final product release activities, as needed, in accordance with established procedures and production schedules. 

Job Requirements


  • BS/BA in Engineering or a technical field or equivalent experience
  • 5+ years experience in quality field in a medical device or similarly regulated industry
  • Experience in the product development life cycle of Electro-Mechanical Devices or Software/Hardware within a regulated industry
Desired Skills:
  • Working knowledge of ISO 13485 and ISO 14971 preferred
  • Effective presentation/communication skills, project/resource management skills.
  • Ability to work independently and in a team environment.
  • Demonstrated problem solving and root cause analysis skills
  • Demonstrated ability to meet project timelines
Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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.