Senior Quality Assurance Engineer
Listed on 2026-03-08
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Engineering
Quality Engineering, QA Specialist / Manager -
Quality Assurance - QA/QC
Quality Engineering, Quality Control / Manager, QA Specialist / Manager
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Life Sciences, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact—innovating at the speed of life.
We know time is the most critical facet in the laboratory today: time to get life‑saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results. We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.
It’s all part of our time‑tested approach to bringing meaningful innovations at the speed of life since 1935. Working together, let’s put our time and talents together to advance human health for tomorrow.
Learn about the Danaher Business System which makes everything possible.
In This Role, You Will Have The Opportunity To- Represent Quality Assurance on cross‑functional teams tasked with business critical initiatives ranging from quality improvement projects to new product transfers and launches.
- Apply your insight of current industry standards and manufacturing best practices, and how they relate to internal policies and procedures; influence interpretation of internal policies and procedures to ensure quality and compliance.
- Monitor and analyze quality performance:
First‑Pass Yield (FPY), Defect Per Unit (DPU), Complaints and other necessary Quality metrics to ensure high product quality and process improvement opportunities are identified. - Work closely with Manufacturing, Manufacturing Engineering, Development, Technical Support, and Suppliers to identify improvement opportunities and drive problem‑solving activities using quality engineering tools.
- Working knowledge of ISO 9001 & ISO 13485 standards, and 21 CFR Part 820 & EU MDR/IVDR regulations.
- Bachelor’s Degree (minimum) in engineering or other science or related field; or equivalent experience required.
- 5+ years’ experience (or 3+ with Master’s Degree) in engineering, manufacturing and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries.
- Effective leadership, communication, interpersonal, and problem‑solving skills.
Travel requirements < 10% of the time, domestic and international.
- Overnight travel may be required.
- Be able to occasionally lift and/or move up to 40 pounds.
- Process Validations, either through development of validation strategies, plans, & protocols or execution and reporting.
- Quality Engineering tools such as Six Sigma, DMAIC, Statistical Process Control, 5 why’s, 8D, PFMEA, Design of Experiment, etc.
- Oracle as an ERP and IQVIA as an eQMS.
Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real‑life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit
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