QA - Complaint Handling Unit Investigator

DanaherIndianapolis, IN
18h

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 QA - Complaint Handling Unit Investigator is responsible for managing, analyzing, and resolving customer complaints. 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 Manager of Quality Assurance – Complaint Handling and is part of the Quality & Regulatory Affairs organization located in Indianapolis, IN. In this role, you will have the opportunity to: Investigate and close safety as well as quality complaint records related to Beckman Coulter Life Sciences instruments and consumables. Investigate and close product feedback records and business process feedback records related to Beckman Coulter Life Sciences instruments and consumables. Escalate potential issues demonstrated from complaint handling records as identified. Represent Complaint Handling on cross-functional teams tasked with important quality improvement initiatives. Support regular gathering of data to report out on metrics during team Daily Management.

Requirements

  • Bachelor’s Degree experience (minimum) in engineering, other science or related field; or equivalent experience required
  • 2+ years’ experience in quality, engineering, 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.

Nice To Haves

  • Complaint Handling, SmartSolve, ServiceMax, Microsoft Office (especially Word and Excel), Oracle
  • Plastics injection molding, Life Sciences instruments, and/or Life Sciences consumables

Responsibilities

  • Investigate and close safety as well as quality complaint records related to Beckman Coulter Life Sciences instruments and consumables.
  • Investigate and close product feedback records and business process feedback records related to Beckman Coulter Life Sciences instruments and consumables.
  • Escalate potential issues demonstrated from complaint handling records as identified.
  • Represent Complaint Handling on cross-functional teams tasked with important quality improvement initiatives.
  • Support regular gathering of data to report out on metrics during team Daily Management.

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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