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

Date Posted: 4/8/2018

Job Snapshot

Job Description

Job ID: BEC008462

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 http://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


  • Ensure compliance to design change procedures, corporate policies and global regulations (FDA QSR, ISO, etc.) and make decisions/provide guidance to prevent a deviation or non-conformance.

  • Observe opportunities for potential risk in established instrument designs and manufacturing processes and implement corrective action as necessary.

  • Identify opportunities for improvement of policies, procedures and methods; collaborate with stakeholders to streamline processes. 

  • Effective interaction with development, technical operations and manufacturing staff to ensure quality, strive minimize the costs of reworking or waste and maximize customer satisfaction with the products.

  • Establish and drive to daily management actions for quality processes that support corporate initiatives.


•         Collaborate with cross functional teams for investigating, designing and improving mechanical systems including motion control, fluid handling, electro-mechanical system hardware, and packaging.



•         Assess risk associated with: (i). design changes; (ii). Internal product non-conformances, (iii). External post launch issues.



•         Evaluate quality system performance and lead kaizen events to improve process efficiency and effectivity.



•         Efficient problem solving using quality improvement tools including: (i).quantitative and categorical analysis of data to understand largest contributors of problems; (ii). fishbone diagrams; (iii). process flow diagrams/ value stream maps; and (iv). root cause analysis. 

Job Requirements



Qualifications


  • Bachelors degree in Engineering with 5+ years experience; Masters degree with 3+  years experience; or PhD degree with 0-2 years experience.

  • Demonstrated: (i). application of compliance to FDA 21CFR820 and ISO 13485 Quality systems requirements; (ii). ability to work well in a cross functional team setting; (iii). application of ISO 14971; (iv). experience with lean manufacturing; and (v). experience in IQ/OQ/PQ and Process Monitoring & Controls.  

  • Good written and oral communication skills.

  • Good Microsoft office skills, including excel and other spreadsheet

  • Work experience in operations and continuous improvement.

  • ASQ CQE certification strongly preferred.



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.