Job Description: Job ID: COR001188
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!
Manage the quality personnel supporting the manufacturing and laboratory operations.
Oversee the incoming, in-process and finished goods inspection areas.
Manage the laboratory operations.
Coordinate Material Review Board (MRB) meetings and drive timely closure of non-conformance reports.
Apply scientific approaches (i.e. quality engineering principles) to drive product quality improvement to meet/exceed quality objectives.
Support supplier quality and customer complaint investigations.
Manage the facility calibration program.
Direct validation activities supporting process validation protocols and new product development initiatives.
Manage daily performance reporting metrics for quality inspection and laboratory operations.
Enforce required facility safety requirements.
Complete staff performance appraisals and support execution of their development plans.
Embrace Danaher/Leica Biosystems philosophy regarding continuous improvement, associate engagement/development and customer satisfaction.
Support investigations related to regulatory compliance and quality systems matters.
Conduct internal and supplier audits, as required.
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.
7-10 years' experience in a medical device (Class I/II)/pharmaceutical manufacturing (incoming/in process/finished goods) and quality laboratory testing environment.
At least 3 years' experience as a supervisor (manufacturing/laboratory).
Experience in supporting internal and external (i.e. FDA/ISO) audits
Experience in supporting process validations and managing calibration programs.
The ability to adapt in an environment of change, uncertainty, and ambiguity. Can pragmatically make decisions in a timely fashion, especially when there is not a clear path.
Excellent problem solving and presentation skills, learns a new environment quickly.
Has the charisma and credibility to communicate and influence change at all levels within the organization;
Identifies, communicates and implements the key priorities to the organization with little guidance or direction;
Spontaneous recognition of problems and opportunities. High sense of urgency.
Outstanding time and project management skills.
BS or Engineering Degree; MBA preferred
ASQ Certifications (i.e. CQE; Quality Auditor; Supplier Quality; Lean/Six-Sigma)
Working knowledge of ISO 13485:2016; MDSAP; ISO 9001:2015
Quality Engineering, Quality Systems and Supplier Quality Management Courses
Travel: Up to 10%
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.