Overview
Quality Assurance Scientist II role at Beckman Coulter Diagnostics.
The Quality Assurance Scientist II for Beckman Coulter Diagnostics is responsible for the disposition and investigation of customer complaints for the Chemistry product line. This position is in the global Complaint Handling Unit and can be located within commutable distance to Lismeehan, Ireland. This onsite role supports post-market quality activities to meet the needs of our global partners, customers, and regulators by providing thorough and timely complaint handling. The role reports to the Post Market Quality Assurance Manager and ensures complaints are accurately classified, records are populated per current procedures and policies, and are investigated promptly.
Responsibilities
* Review, investigate and disposition safety and quality complaints and customer feedback in compliance with established procedures and regulations.
* Work with the Post Market Investigation team to design, perform, and complete investigations into alleged product non-conformances.
* Perform risk assessments, complete stop ship decision summaries, and CAPA requests in accordance with established procedures.
* Identify and/or participate in process and product improvements through projects, kaizens, CAPA and department initiatives. Facilitate cross-functional meetings.
Essential Requirements
* Bachelor's degree with 2+ years’ experience in technical field (Science or Engineering) and/or compliance (Complaints, Quality or Regulatory).
* Good computer skills including Outlook and Microsoft Word, Excel, and PowerPoint.
Preferred/Additional Experience
* Experience in Complaint Investigation or Post Market Surveillance/QA.
* Medical Technology/clinical laboratory background.
Additional Details
* For more information, visit www.danaher.com.
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
Industries
* Medical Equipment Manufacturing
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