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Quality Systems Engineer in Buffalo Grove, Illinois at Leica Biosystems

Date Posted: 12/4/2018

Job Snapshot

Job Description

Job ID: SEL001606

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 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.
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Description

  • This position will be responsible for supporting the Regulatory Affairs and Quality Assurance initiatives at Leica Biosystems (LBS) Buffalo Grove.  The position will provide Regulatory and Quality support in the maintenance and improvement of facility/corporate wide quality management systems and support processes to ensure compliance with applicable regulations and standards.  The Quality System Engineer is experienced in multiple areas of medical device Regulatory Affairs and Quality Assurance and is capable of applying that experience and knowledge across Leica and Danaher as a representative on improvement initiatives.
  • Support quality system to ensure compliance to all applicable requirements and standards (FDA Part 820, 803, 806, Part 11, Health Canada and ISO 13485) and implement process improvements to ensure continued compliance and sustained improvements
  • Supports Quality System element compliance (i.e. Document Control, Training, Complaints, Management Reviews, Internal Audits, etc.) for RA/QA and other departments including Sales, Marketing, Customer Support, etc.
  • Assist with Recall activities, MDR investigations, manage CAPA’s and complete site Internal audits
  • Assist with implementation of electronic Quality Management Systems and serves as site’s technical Subject Matter expert for those systems
  • Participate in development of training materials and conduct training sessions for personnel on applicable site Regulatory and Quality regulations/requirements along with product specific Regulatory training (i.e. complaint handling and adverse event escalation, classification of products, product claims)
  • Presents quality performance metric data to QA/RA Management and other technical cross-functional area owners to improve the Quality Management System and drive increased system compliance
  • Provide technical, regulatory and quality support to Customers, Leica personnel and other OpCo’s
  • Support other sites in their maintenance and improvement of local Quality systems; design, engineering, manufacturing and operations activities to improve performance in design and manufacturing quality assurance

Job Requirements



Qualifications

  • Training and Experience
  • 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 Auditor (CQA) Certification, ISO13485 Lead Auditor or equivalent experience.
  • Certified Quality Technician (CQT), Certified Quality Engineer (CQE) or equivalent experience.

  • Knowledge, Abilities and Skills
  • Proficiency in MS Office, including Excel, Word, and Powerpoint.
  • 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.
  • Specific experience in driving compliance of quality systems.
  • Experience with problem solving and continuous improvement tools is required.  

  • Travel 5%


  • 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.
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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.