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. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Beckman Coulter Life Sciences, 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. And we’re just beginning. 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.
The Senior Quality Assurance Engineer is responsible for owning quality related processes in an instrument manufacturing environment, guiding cross-functional teams through Beckman’s quality management system requirements, and ensuring product quality for Beckman’s customers.
This position reports to the Senior Manager - Manufacturing Quality and is part of the Quality & Regulatory Affairs organization located in Indianapolis, IN. This will be an on-site role.
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.
- Monitoring and analyzing 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 driv problem solving activities using quality engineering tools.
The essential requirements of the job include:
- 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, Motor Vehicle Record & Physical/Environment Requirements:
- 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.
It would be a plus if you also possess previous experience in:
- 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 www.danaher.com.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [email protected].
Skills Required
- Working knowledge of ISO 9001 & ISO 13485 standards
- Bachelor's Degree in engineering or related field
- 5+ years' experience in engineering or quality systems
- Effective leadership, communication, and problem-solving skills
Beckman Coulter Diagnostics Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Beckman Coulter Diagnostics and has not been reviewed or approved by Beckman Coulter Diagnostics.
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Healthcare Strength — Healthcare coverage is described as comprehensive, including medical, dental, vision, life and disability insurance, flexible spending accounts, and mental health support. Feedback suggests these offerings are a notable strength of the overall package.
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Leave & Time Off Breadth — Paid time off, paid holidays, sick days, and volunteer time are highlighted, with flexibility or remote arrangements available for some roles. Feedback suggests this breadth of time-off options contributes meaningfully to total rewards.
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Parental & Family Support — Paid parental leave is provided for birth, adoption, or foster placement with the ability to use time in flexible increments within the first year. Feedback suggests family-focused perks like adoption support add tangible value for caregivers.
Beckman Coulter Diagnostics Insights
What We Do
Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology, and the passion and creativity of our teams to enhance the diagnostic laboratory’s role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.
