Staff Quality Assurance Engineer

Danaher•Indianapolis, IN

63d•Onsite

About The Position

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.

Requirements

Working knowledge of ISO 9001 & ISO 13485 standards, 21 CFR Part 820, EU IVDR regulation, and similar global regulations (MDSAP, etc.).
Bachelor's Degree (minimum) in engineering or other science or related field; or equivalent experience required.
7+ years' experience (or 4+ 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.

Nice To Haves

Development of validation strategies, plans, protocols and reporting.
Quality Engineering tools such as Six Sigma, DMAIC, Statistical Process Control, 5 why's, 8D, PFMEA, Design of Experiment, etc.
Project Management

Responsibilities

Represent Quality Assurance or lead 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.
Design and deliver training programs on cGMP, GDP, and other quality standards. Ensure training effectiveness through assessments and retraining strategies, maintaining alignment with quality, regulatory and internal requirements.
Coach teams with application of ISO 9001/13485/cGMP/MDSAP and quality systems processes throughout product lifecycle.

Benefits

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.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

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