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Supplier Quality Engineer - Richmond IL in Richmond, Illinois at Leica Biosystems

Date Posted: 3/15/2019

Job Snapshot

Job Description

Job ID: COR001343

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!


Description

The Quality Engineer will support manufacturing and supplier quality by identifying opportunities for quality / process improvement.

Primary Responsibilities

  • Applies CAPA’s to lead root-cause investigations for acute manufacturing and process defects
  • Process Owner for the control of non-conforming product, responsible for dispositioning and educating QC inspectors on the handling of non-conforming product; trends and monitors Non-conforming Reports (NCR’s) to identify areas for continuous improvement
  • Fosters a manufacturing culture of data-driven problem solving to identify and implement process improvements 
  • Leads process and product audits as well as internal Quality System audits.
  • Works with key suppliers to identify critical requirements to ensure quality of supplied parts/components; supports qualification of new suppliers or changes to existing suppliers
  • Responsible for creating and communicating supplier quality scorecards
  • Conducts supplier audits according to ISO 13485:2016 and ISO 9001:2015 and maintains supplier audit schedule
  • Issues and follows up on Supplier Corrective Action Requests (SCAR’s), providing technical direction to suppliers where applicable

Job Requirements



Qualifications

  • Training and Experience
  • Bachelor’s Degree in Engineering or Scientific Field required
  • Minimum three (3) years' experience in a technical or quality role preferably in a medical device ISO 13485 certified facility preferred
  • Certified Quality Technician (CQT), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) Certification or equivalent experience preferred.
Knowledge, Abilities and Skills
  • Thorough statistical knowledge of acceptance sampling, process capability and stability analyses, and comparative inferential statistical tools (hypothesis testing, ANOVA, etc.)
  • Fluency in Minitab Statistical Software preferred
  • Proficiency in MS Office, including Excel, Word, and Powerpoint.
  • Able to read and understand engineering drawings/specifications
  • Strong communication skills, both orally and written, at all levels of an organization.
  • Strong understanding of cGMP, ISO 13485, ISO 9001 and FDA Quality Systems; work experience in an FDA regulated company preferred.
Travel: approx 15% 

*LI-TH1.


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.