Danaher Corporation Staff QA Scientist - Medical Device/DX Chaska in Chaska, Minnesota
Danaher Company Description
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 atwww.beckmancoulter.com. 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.
* Provide design control and risk management oversight to various development projects. Serve as back up Risk Manager where required. * Facilitate risk assessments for new designs and design changes at various project development phases. Ensure that risk management activities are performed in accordance with company procedure * Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans. This includes evaluating gaps for IVDR, generating plans for addressing the gaps and ensuring successful implementation of standards/procedures to support IVDR compliance * Provide guidance to project teams on project specific processes and deliverables. Ensure key elements of product developments are documented in design and development plan or design change plan. Ensure Plans are established and updated timely * Generate and analyze customer feedback data to improve product reliability and performance for our customers that is within the scope of the project * Support development of concise and complete verification and validation strategies that efficiently generate bodies of objective evidence to confirm product requirements compliance and the global regulatory submission strategy. Ensure all test anomalies/deviations are investigated, cause determined, impact assessed, plan of action defined, and resolution is verified * Ensure the product Design History File (DHF) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needs * Drive continuous improvement of new product development procedures, methods, tools, techniques, and training, etc. to support project specific efficiencies. 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.
* BS in Biochemistry, Immunology or related technical field with minimum of 9 years of experience or Master’s degree in field with minimum of 7 years of experience, or Doctoral degree with 4 years of experience * Demonstrated skills in design control processes, including design change, risk management, design requirements, design V&V, and design transfer. * Fluent in English language * Proficient in word processing, spreadsheets, MS PowerPoint, and project management skills * Well-developed written and oral skills * Minimum 2 years of experience in QA, design assurance or demonstrated skills in the new product development process preferred * Strong technical background in areas of reagent development or similar related function * Knowledge in instrumentation including system integration (hardware, software, reagents) * Ability to perform detail-oriented work with a high degree of accuracy; * Working knowledge of US and International regulations and standards (QSR, ISO, CE-IVD, GLP, cGMP, CLIA, Japan GMP, CMDR) * Experience in Verification and Validation & Product Submission/Registration * Experience in transferring new products from design to production; * Effectively communication skills to ensure positive outcomes across a multidisciplinary team * Strong technical writing skills * Risk Specialist, with full understanding of risk management regulations (ISO 14971), and principles and practices * Skilled in the use of risk management tools such as PLRAs, SRAs, and Risk Management Plans and Reports * Working knowledge of statistical techniques and quality/reliability tools (FMEA, FTA, DOE, SPC, etc) * Proficient in data analysis with experience using issue analysis/problem solving tools (root cause analysis, PSP, etc) * Ability to support several projects simultaneously while effectively adapting to changing project parameters * Mobility Requirements: Stand/Sit/Walk 8 hours/day; ability to travel across campus and between facilities * Dexterity Requirements: Able to use computer & monitor to develop, review and communicate job-related documentation * Vision Requirements: Correctable to 20/20 in 1 eye and 20/40 in other eye. Able to use computer & monitor to develop, review and communicate job-related documentation. * Hearing requirements: Able to participate in meetings and conference calls and to use a telephone. * Minimal travel as needed, <5%
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.
Organization: Beckman Coulter - Diagnostics
Job Function: Science
Primary Location: North America-North America-United States-MN-Chaska
Req ID: BEC012591