Quality Assurance Engineer

DanaherIndianapolis, IN
22hOnsite

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 Quality Assurance Engineer is responsible for supporting quality related processes in a high-volume, injection molding manufacturing environment. The role will collaborate with cross-functional teams to investigate product discrepancies, process improvement opportunities, and/or compliance risks, with the end goal of 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 important quality improvement initiatives. Facilitate non-conforming material reviews – quarantining of non-conforming product and investigating root causes. Investigate customer complaints and recommend countermeasures. Audit the manufacturing process and associated records to ensure compliance with documented procedures. Support validation activities to qualify processes, tools, equipment, and test methods.

Requirements

  • Bachelor’s Degree experience (minimum) in engineering or other science or related field; or equivalent experience required
  • 2+ years’ experience in engineering, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries or Master's degree in field with 0 - 2 years experience.
  • Effective communication, interpersonal, and problem solving skills.
  • Travel is not expected for this role
  • Be able to occasionally lift and/or move up to 40 pounds.

Nice To Haves

  • Quality Engineering tools such as Six Sigma, DMAIC, Statistical Process Control, 5 why’s, 8D, PFMEA, Design of Experiment, etc.
  • Plastic injection molding

Responsibilities

  • Represent Quality Assurance on cross functional teams tasked with important quality improvement initiatives.
  • Facilitate non-conforming material reviews – quarantining of non-conforming product and investigating root causes.
  • Investigate customer complaints and recommend countermeasures.
  • Audit the manufacturing process and associated records to ensure compliance with documented procedures.
  • Support validation activities to qualify processes, tools, equipment, and test methods.

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 .
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