Associate Director Clinical Quality Assurance Jobs in Indianapolis, IN
Associate Director Clinical Quality Assurance jobs in Indianapolis are concentrated in the life sciences and pharmaceutical corridor anchoring the north side, with strong clusters in Meridian-Kessler, Fishers, and the Lilly Campus district. Demand is active across clinical research organizations, pharma manufacturers, and contract development organizations, and employers hiring right now include Cardinal Health, Elanco, and American Technology Consulting. See the openings below and apply to the ones that match your experience.
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Showing 5 of 19+ Associate Director Clinical Quality Assurance jobs
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 Staff Quality Assurance Engineer is responsible for owning quality related processes, 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 regulations and how they relate to internal policies and procedures. Influence interpretation of internal policies and procedures to ensure quality and compliance.
Serve as a local process owner and subject matter expert for Production & Process Controls as well as other manufacturing related QMS processes.
Coach teams with application of ISO 9001/13485/cGMP and quality systems processes throughout product lifecycle
Leverage data analytics and business intelligence tools to identify quality trends, monitor process performance, drive risk-based decision making, and communicate actionable insights to leadership
The essential requirements of the job include:
Demonstrated experience supporting the manufacture of medical device instruments, electromechanical systems, laboratory instrumentation, diagnostic analyzers, automation platforms, or similar complex medical devices.
Proven experience applying quality and regulatory requirements to manufacturing processes, process validation, equipment qualification, nonconformance management, CAPA, risk management, and continuous improvement activities.
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.
7+ years' experience (or 4+ years with Master's Degree) in Quality Engineering, Manufacturing Engineering, or Quality Systems within regulated industries.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Travel requirements < 20% 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:
Advanced Power BI (or similar) capabilities including data modeling, DAX development, Power Query, dashboard design, KPI development, and integration of data from ERP, eQMS, manufacturing, and other enterprise systems
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.
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 Staff Quality Assurance Engineer is responsible for owning quality related processes, 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 regulations and how they relate to internal policies and procedures. Influence interpretation of internal policies and procedures to ensure quality and compliance.
Serve as a local process owner and subject matter expert for Production & Process Controls as well as other manufacturing related QMS processes.
Coach teams with application of ISO 9001/13485/cGMP and quality systems processes throughout product lifecycle
Leverage data analytics and business intelligence tools to identify quality trends, monitor process performance, drive risk-based decision making, and communicate actionable insights to leadership
The essential requirements of the job include:
Demonstrated experience supporting the manufacture of medical device instruments, electromechanical systems, laboratory instrumentation, diagnostic analyzers, automation platforms, or similar complex medical devices.
Proven experience applying quality and regulatory requirements to manufacturing processes, process validation, equipment qualification, nonconformance management, CAPA, risk management, and continuous improvement activities.
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.
7+ years' experience (or 4+ years with Master's Degree) in Quality Engineering, Manufacturing Engineering, or Quality Systems within regulated industries.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Travel requirements < 20% 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:
Advanced Power BI (or similar) capabilities including data modeling, DAX development, Power Query, dashboard design, KPI development, and integration of data from ERP, eQMS, manufacturing, and other enterprise systems
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.
See All 19 Associate Director Clinical Quality Assurance Jobs in Indianapolis
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Find JobsAssociate Director Clinical Quality Assurance Job Market in Indianapolis
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Top Industries Hiring
- Distribution & Wholesale
- Healthcare & Medical Services
- Biotechnology & Pharmaceuticals
- Consulting & Professional Services
Associate Director Clinical Quality Assurance Jobs in Indianapolis: Frequently Asked Questions
How do I get a associate director clinical quality assurance job in Indianapolis?
The strongest path in Indianapolis runs through its dense pharmaceutical and clinical research sector, where Eli Lilly's campus and a surrounding ecosystem of contract research organizations, biotech firms, and medical device companies cluster on the north side and in nearby Fishers and Carmel. Candidates who stand out combine GCP and FDA regulatory experience with demonstrated leadership over QA teams. Familiarity with oncology or neuroscience programs is a frequent advantage in this market.
Which companies hire associate director clinical quality assurances in Indianapolis?
Companies currently hiring associate director clinical quality assurances in Indianapolis include Cardinal Health, Elanco, and American Technology Consulting, per current listings on Migrate Mate as of July 2026. Indianapolis employers in this space range from global pharmaceutical giants and their local subsidiaries to mid-size contract research organizations and specialty biotech firms anchored around the city's life sciences corridor.
Are there remote associate director clinical quality assurance jobs in Indianapolis?
Yes, though availability is limited because the role involves overseeing audit readiness, site inspections, and hands-on team management that often require an on-site presence. About 30% of associate director clinical quality assurance openings tied to Indianapolis are remote or hybrid as of July 2026, with remote work most common for SOP development, regulatory submission review, and compliance documentation oversight at Indianapolis-based clinical operations firms.
How can I get a associate director clinical quality assurance job in Indianapolis with little or no experience?
The most realistic entry path in Indianapolis is moving up through quality assurance specialist or senior QA associate roles at one of the city's contract research organizations or mid-size pharma manufacturers, many of which actively develop internal talent. Gaining experience with FDA inspection preparation and CAPA management in those roles builds the credentials this level requires. Local biotech startups around the 16 Tech innovation district also offer earlier director-track exposure than larger enterprises typically do.
Which industries hire the most associate director clinical quality assurances in Indianapolis?
Most associate director clinical quality assurance openings in Indianapolis sit in Distribution & Wholesale, Healthcare & Medical Services, and Biotechnology & Pharmaceuticals, per current listings on Migrate Mate as of July 2026. Indianapolis's standing as a global pharmaceutical hub, anchored by major research and manufacturing operations and supported by a network of clinical service providers, makes those sectors the primary and consistent source of demand for this role locally.
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See All 19 Associate Director Clinical Quality Assurance Jobs in Indianapolis
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