Staff Quality Assurance Engineer

Danaher; Indianapolis (IN); On-site; USD 85,000 - 115,000; Full time

Job summary

Join a leading company in life sciences as a Staff Quality Assurance Engineer or Scientist in Indianapolis. You will facilitate quality systems and design control processes across innovative products, ensuring compliance and advancing human health through quality improvements. This on-site role offers a dynamic environment and responsibilities that drive impact within the organization.

Benefits

Comprehensive health care

Paid time off

Qualifications

• BS + 7 or MS + 4 years’ experience in product development, manufacturing, or quality systems.
• Experience in regulated industries such as medical devices or pharmaceuticals.

Responsibilities

• Represent quality assurance on development teams and quality systems.
• Coach teams on ISO standards and quality processes.
• Ensure compliant process and product documentation.

Skills

Quality Assurance

ISO 9001

cGMP

Risk Management

Education

Degree in engineering or science

Job description

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 your unique viewpoint matters. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Since 1935, Beckman Coulter Life Sciences has been committed to bringing meaningful innovations at the speed of life. We understand that time is critical in the laboratory: delivering life-saving therapies faster, automating manual workflows to reclaim time, and reducing errors and complex results.

We are partners in time, accelerating answers to critical questions through automation. Our innovations are developed by scientists for scientists, with over 3,300 global colleagues, many coming from laboratory backgrounds.

Learn about the Danaher Business System, which enables our success.

Position Overview:

The Staff Quality Assurance Engineer or Scientist is responsible for facilitating the application of quality systems and design control processes across Beckman Coulter Life Sciences products, including instrumentation, software, and consumables.

This role reports to Jim Taller and is part of the Development Quality Team located in Indianapolis. It is an on-site position.

Key Responsibilities:

• Represent quality assurance on development teams, quality systems, and product improvement projects.
• Coach teams on ISO 9001/13485/cGMP/IEC 62304 and quality processes throughout the product lifecycle.
• Partner cross-functionally to ensure product and service conformance, focusing on Design Controls, Document Controls, Risk Management (ISO 14971), Production, and Service Controls.
• Ensure compliant process and product documentation, including Design History, Product, Process, and Service documentation, supporting product realization and commercialization.
• Stay informed of industry standards and regulations, interpreting internal policies to ensure quality and compliance.

Minimum Requirements:

• Degree in engineering, science, or related field; or equivalent experience.
• BS + 7 or MS + 4 years’ experience in product development, manufacturing, or quality systems (ISO 9001), medical devices (ISO 13485), pharmaceuticals, or related regulated industries.

Preferred Qualifications:

• Experience in identifying, developing, and executing quality improvements, driving cross-functional change.
• Certified Software or Quality Engineer (SQA) and/or Auditor Certification preferred.
• Experience with software development lifecycle management.

Beckman Coulter Life Sciences offers comprehensive benefits, including health care and paid time off, contributing to life beyond work. More details at Danaher Benefits.

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Join us in advancing human health through science and technology. Visit www.danaher.com for more information.

Danaher Corporation and its subsidiaries are committed to equal opportunity employment. We value diversity and encourage individuals of all backgrounds to apply.

The EEO posters are available here. For accommodation requests, contact [e-mail].