Sr Quality Assurance Analyst – IVD/Medical Device Design Control in Brea, California at Beckman Coulter Diagnostics

Date Posted: 3/9/2018

Job Snapshot

Job Description

Job ID: BEC008185

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

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.


The Senior Quality Assurance associate will be responsible for various hardware/software/system development projects.


  • Provide design control and risk management oversight to various development projects.

  • Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans

  • 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

  • Write design validation protocols, execute testing and write design validation reports

  • 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

  • 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

  • Collaborate with the Post Market Surveillance (PMS) team

Job Requirements


  • Bachelor’s degree in chemistry, biology, biochemistry and/or medical technology with 5+ years’ experience in IVD, Medical Device, or Biotechnology organization preferred OR Master’s degree in a scientific filed with 3+ years’ experience

  • CQE certified is preferred

  • Strong skills in problem solving and in-depth data analysis on products and processes

  • Strong skills in root cause investigation and problem solving

  • Ability to perform detail-oriented work with a high degree of accuracy

  • Working knowledge of US and International regulations and standards

  • Familiar with risk management tools such as PLRAs, SRAs, and Risk Management Plans and Reports

  • Experience with the medical device industry within a Quality Assurance is preferred

  • Knowledge of FDA regulations and ISO standards is preferred

  • Must have critical thinking skills and good judgment working in an independent environment while handling Quality Assurance tasks

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.