Sr Quality Assurance Engineer - Med Device Validation in Chaska, Minnesota at Beckman Coulter Diagnostics

Date Posted: 1/31/2018

Job Snapshot

Job Description

Job ID: BEC009104

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 Senior QA Engineer will be a member of a team responsible for the training, mentoring and oversight of validation-related activities.  The individual will assist in the sustainment of a robust Master Validation Plan and support of the MVP strategies.  The individual will be responsible for understanding customer (internal and external) requirements, and with minimal guidance, developing test cases and validation-related documents and procedures especially in the area of equipment qualification.  Working knowledge of computer controlled and automated equipment qualification is required. 



Responsibilities



  • Training and mentoring of individuals and validation teams to ensure efficiency and compliance in both formal (classroom style) and informal training

  • Adherence to defined corporate and local validation practices and procedures while monitoring the state of the industry to ensure that BEC utilizes current best practices

Job Requirements



Qualifications

Required Skills & Experience



  • Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences or related with 6 years' relevant experience, or Master’s degree and 4 years' relevant experience, or PhD and 2 years' relevant experience

  • ASQ CQE and experience in the medical device industry strongly preferred

  • Excellent understanding of software, test method, equipment, process and design testing methodologies

  • 3 or more years of experience in acceptance sampling, test designs, and procedures

  • Able to evaluate specifications and requirements for completeness and testability

  • Able to generate test cases and procedures from specifications with minimal guidance

  • Able to execute test procedures with minimal guidance

  • Experience with testing object-oriented and process-based systems, including process capability assessment

  • Experience in testing of systems, preferably related to medical devices

  • Experience with 21 CFR 820, ISO 13485, GHTF Process Validations


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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% 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.