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

Date Posted: 2/8/2018

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 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.