Quality Systems Manager in Richmond, Illinois at Leica Biosystems

Date Posted: 4/16/2018

Job Snapshot

Job Description

Job ID: COR000971

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

Provide company leadership in the implementation, maintenance, and improvement of facility/corporate wide quality management systems and support processes. Proactively manage the various elements of the quality system to ensure compliance with applicable national and international quality system regulations.



Primary Responsibilities




  • Provide hands-on ownership for the various elements of the quality system including Corrective/Preventive Action (CAPA), Validations, Customer Complaints, Risk Management, Document Control, Management Reviews, ISO:13485:2016, MDSAP, Training, and Internal Audits to ensure successful performance during third party audits

  • Actively manage the implementation, maintenance, and improvement of quality systems based on established direction and priorities

  • Ensure efficient and effective processes and tools are established for compliance with QSR requirements and continually improved

  • Provide support to internal functions in the application, maintenance and improvement of quality systems and department specific processes

  • Act as the quality representative for various the project teams design development

  • Prepare regular performance reports and metrics for Quality Management Systems, assist other departments in establishing and mining databases to support quality and management objectives

  • Ensure the delivery of the People Strategy within area of accountability

  • Manage, coach and develop a high performing Quality System team that meets agreed objectives and which delivers best practice results, added value and continuous improvements

  • Manage and lead the team, ensuring adequate staffing levels

  • Motivate and coach the team to operational success 

Job Requirements



Qualifications



  • BS/BA in engineering, business management or equivalent experience; MBA, ASQ Certifications (i.e. Auditor, Six-Sigma Black Belt, PMP) a plus

  • 5-7 years experience in a medical device environment, prefer 2-4 years in a management level position

  • Experience with FDA audits essential

  • Quality System management experience in a medical device manufacturing environment or equivalent

  • Direct experience with ISO 13485:2003/2016, ISO-14971, MDSAP, Management Reviews, Internal Audits, Training, CAPA, Customer Complaint Management, Document Control, Validation and FDA QSRs.

  • Excellent interpersonal skills with all levels of employees

  • Project and personnel management skills

  • Demonstrated working knowledge of quality systems requirements and process ownership

  • Excellent interpersonal skills with all levels of associates

  • Project and People Management Skills

  • Excellent time management and organization skills are a must

Travel



  • 10% - 15% Travel Possible



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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% 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.