Quality Engineer - Quality Systems

Danaher Richmond , IL 60071

Posted 2 months ago

Job Description: Job ID: COR001200

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

  • Designs quality trending systems to monitor the effectiveness of key quality performance metrics affecting areas such as CAPA's, Complaints, Non-conformance Reports (NCR's)

  • Compiles and analyzes quality performance metric data to determine key metric drivers, using tools such as time-series plots, control charts and pareto graphs

  • Presents quality performance metric data to QARA Management and other technical cross-functional Area Owners to improve the Quality Management System and drive increased system compliance

  • Leads implementation of electronic Quality Management Systems and serves as site's technical Subject Matter expert for those systems

  • Works closely with Design Engineering, Manufacturing Engineering and Operations counterparts to standardize and improve performance in design and manufacturing quality assurance

  • Leads process and product audits as well as internal Quality System audits.

  • Leads complaint investigations for high risk or high complexity customer complaints that warrant substantial technical & engineering support.

  • Fosters a team culture of data-driven problem solving, through the education of Manufacturing Engineering and Operations Personnel on the use of Quality Engineering tools, such as statistics, root cause analysis (5-Why's, Ishikawa analysis), and measurement system analyses (Gauge R&R, Gauge Correlation Studies).

  • Supports Quality System element compliance (i.e. Document Control, Training, Complaints, Management Reviews, Internal Audits, etc.) and other departments including Sales, Marketing, Customer Service, etc.

  • Supports Recall and MDR investigations.

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.

Job Requirements

Qualifications

  • Bachelor's Degree in Engineering or Scientific Field

  • Minimum (5) years of experience in a technical or quality role preferably in a medical device ISO 13485 certified facility.

  • Certified Quality Technician (CQT), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) Certification or equivalent experience.

  • 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 and the presentation of complex quantitative data

  • 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: 5%

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.


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VIEW JOBS 9/26/2018 12:00:00 AM 2018-12-25T00:00 * Designs quality trending systems to monitor the effectiveness of key quality performance metrics affecting areas such as CAPA's, Complaints, Non-conformance Reports (NCR's) * Compiles and analyzes quality performance metric data to determine key metric drivers, using tools such as time-series plots, control charts and pareto graphs * Presents quality performance metric data to QARA Management and other technical cross-functional Area Owners to improve the Quality Management System and drive increased system compliance * Leads implementation of electronic Quality Management Systems and serves as site's technical Subject Matter expert for those systems * Works closely with Design Engineering, Manufacturing Engineering and Operations counterparts to standardize and improve performance in design and manufacturing quality assurance * Leads process and product audits as well as internal Quality System audits. * Leads complaint investigations for high risk or high complexity customer complaints that warrant substantial technical & engineering support. * Fosters a team culture of data-driven problem solving, through the education of Manufacturing Engineering and Operations Personnel on the use of Quality Engineering tools, such as statistics, root cause analysis (5-Why's, Ishikawa analysis), and measurement system analyses (Gauge R&R, Gauge Correlation Studies). * Supports Quality System element compliance (i.e. Document Control, Training, Complaints, Management Reviews, Internal Audits, etc.) and other departments including Sales, Marketing, Customer Service, etc. * Supports Recall and MDR investigations. 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. * Bachelor's Degree in Engineering or Scientific Field * Minimum (5) years of experience in a technical or quality role preferably in a medical device ISO 13485 certified facility. * Certified Quality Technician (CQT), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) Certification or equivalent experience. * 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 and the presentation of complex quantitative data * 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: 5% Radiometer Richmond IL

Quality Engineer - Quality Systems

Danaher