Senior Quality Assurance Scientist in Chaska, Minnesota at Beckman Coulter Diagnostics

Date Posted: 6/20/2019

Job Snapshot

Job Description

Job ID: BEC015272

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 www.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.


Description

The Beckman Coulter Chemistry and Immunoassay product portfolio is diverse and includes new concepts for hardware, software, and clinical decision applications.  The Senior Quality Assurance Scientist associate will support the Development QA functional core team members in the design and development of new products from initiation through market release with an objective to provide high quality, reliable, cost competitive, and regulatory compliant products to market.  

Description
  • The Senior Quality Assurance Scientist associate may be the lead QA for various reagent development and design change projects.  Responsibilities include:
  • Fulfill the Development QA role on Reagent Product Development Core and Design Change Teams as the design progresses through the development process. Understand the product design/process reliability and ensure the creation of documented evidence of compliance to Beckman Quality System and applicable regulatory requirements.
  • Collaborate effectively with other functional group Core Team and Change Team members in defining performance requirements, conducting risk analysis, and verification test plan execution.  Drive to achieve Design for Reliability and Manufacturing results by effective use of applicable Danaher Business System tools.
  • Work with minimal direction to complete assigned project, procedural, assessments, or data analysis task individually or as delegated to quality function specialists within the organization.
  • Ensure that assigned task are compliant to Beckman applicable procedural requirements as well as to FDA QSR, ISO, and other global regulations
  • 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.  
  • Generate and analyze customer feedback data to improve product reliability and performance for our customers that is within the scope of the project;
  • 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.

Job Requirements



Qualifications

Basic Qualifications
  • BS in Biochemistry, Immunology or related technical field with minimum of 5+ years of experience or Master’s degree in field with minimum of 3+ years of experience, or Doctoral degree with 0-2 years of experience
  • 1-2 years of experience within Medical Device product design and/or manufacturing environment.
  • 1-2 years of experience on cross-functional team and/or managing projects involving multiple tasks.
  • Demonstrated knowledge of 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
Desired/Preferred Qualifications (skills and experiences beyond Basic Qualifications)
  • Well-developed skills in writing, review documentation, and oral communication within a technical team. 
  • Practical experience in other Quality disciplines (Supplier, Manufacturing, Design, Post-market Surveillance, Quality Systems, and Quality Control). 
  • Ability to influence decisions within Dev QA function and across functions within product line or project.
  • Experience in reagent product development and manufacturing processes in Life Sciences industry.
  • Working knowledge of statistics and quality/reliability tools in framing and developing solutions to technical issues in product development.
  • Experience in a regulated industry specifically knowledge of IVD and Medical Device industry
  • Ability to support several projects simultaneously while effectively adapting to changing project parameters

Diversity & Inclusion
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.

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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 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.