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 Danahers 15+ operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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.
Its all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And were just beginning. Working together, lets put our time and talents together to advance human health for tomorrow.
The Senior Quality Assurance Engineer is responsible for owning quality related processes in an instrument manufacturing environment, guiding cross-functional teams through Beckmans quality management system requirements, and ensuring product quality for Beckmans 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
Bachelors Degree (minimum) in engineering or other science or related field; or equivalent experience required.
5+ years experience (or 3+ with Masters 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 whys, 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 its 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, well accelerate the real-life impact of tomorrows 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.
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.
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 applyassistance@danaher.com.
