Quality Assurance Manager (m/w/n) in Munich, Germany at Beckman Coulter Diagnostics

Date Posted: 5/8/2018

Job Snapshot

Job Description

Job ID: BEC010169

About Us


Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.


Beckman Coulter 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.


Description

Working within the Workflow and IT Solutions (WITS) Quality & RA organization, the Manager Quality Assurance reports directly to the WITS Director, Quality & Regulatory Affairs. He/she ensures compliance of the products and the design process, including design changes to established products.


S/he leads a team of quality engineers supporting Automation and Informatics product lines. He /she interacts collaboratively with the Product Compliance Group, to ensure the type testing certification such as electrical and electromagnetic compatibility and also compliance to product specific directives such as restriction of Hazardous Substances (RoHS) are in place, and with the Development Group to make sure that applicable standards are met (such as Software development lifecycles and Usability engineering).


He is able to work in a matrix and multicultural environment to drive improvement and simplification. Thanks to his vision of Quality in a regulated environment he’s able to inspire and develop his team and to influence stakeholders in order to improve processes and maintain compliance.




Specific Responsibilities:


• Leads and develops a team of Quality Engineers


• Ensures Design Control compliance


• Drives Design Validation and non-product software validation


• Coordinates Risk Management activities


• Drives improvement of local and global processes associated to design and development

Job Requirements



Qualifications

• Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.
• Successful experience in leading a QRA team in Medical device/IVD industry of 10 years +
• Excellent communication skills and team work
• Excellent practical experience of ISO9001, ISO13485and 21 CFR part 820 Quality System Regulation
• Experience in design validation and generation of associated protocols gained either from in house testing
• Simulating end use or actual end use in a clinical environment
• Computer skills (MS Office products)
• Knowledge of ISO14971, IEC 60601 / IEC 61010 3rd Edition, IEC 62366 and IEC 62304.
• Ability to work cross culturally/functionally and understand functional department requirements
• Proficient in English
• Excellent organizational capabilities
• Highly ethical, is able to multi-task and prioritize in a competitive environment
• Clean driving record – ability to travel as required (may include international travel)



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. A globally diverse team of 71,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2014, we generated $19.9B in revenue and our market cap exceeded $60B. We are #149 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20yrs.

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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