Risk Manager - Medical Devices (m/f/d)

Job Description

Job Description Job ID: BEC015759
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 offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at [ Link Removed ] .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 Beckman Coulter Biomedical GmbH Q&RA organization, the Risk Manager will manage the process of product risk according ISO 14971 in alignment with Workflow & IT Solution (WITS) strategy. The Risk Manager will report into the WITS Senior Manager Quality Management Systems.Specific Responsibilities

• Ensure compliance of the risk management process within WITS Business Units
• Interact with Beckman Coulter Risk management community and more specifically with the global Process Owner and represent WITS business unit within the RM Council
• Deploy, plan and perform risk management activities within WITS organization;
• Maintaining, reviewing and approving risk management documentation (in particular Risk Management Plan, Risk Benefit Analysis, Product Safety Reference, System Risk Assessment, Post Launch Risk Assessment etc.) and coordinate the required technical experts for risk assessment workshops;
• Deploy risk management best practice, standard operating procedures and general guidance for the application of risk management in device development;
• Disseminate knowledge and awareness of risk management within WITS organization;
• Supporting escalation of customer complaints associate to WITS products to MDR / MDV and/or FSCA;
• Subject Mater Expert for Risk Management during internal and external audits and/or inspections;
• Responsible for identifying opportunities for improvement within Risk Management.

Job Requirements
Qualifications

• A Bachelor’s degree or Master’s degree with 5+ years of experience, preferably in areas of life sciences, engineering, or quality assurance;
• Thorough knowledge and expertise in risk management and/or customer complaint management, ideally working experience in the IVD, medical devices or other regulated environment;
• Strong knowledge of regulation: ISO13485 and 21CFR 820.demonstrated skills in risk assessment (sFMEA) and root cause analysis;
• Excellence in the use of 5 Whys or other appropriate root cause investigation tool(s);
• Ability to work in matrix environment and lead interdisciplinary and cross-cultural team member without direct reporting line;
• Ability to quickly establish credibility and trustworthiness with key stakeholders;
• Excellent command of verbal and written English; German is preferred but not required.
• Goal oriented, interpersonal, self-motivated and team player.

Diversity & InclusionAt 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.
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, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.