Senior Quality Assurance Engineer

5 days ago


Indianola, Nebraska, United States Bayer Full time
Job Summary

We are seeking a highly skilled Senior Quality Engineer to lead investigations of customer complaints and Radiology product issues related to electro-mechanical systems and disposables kits. This role will play a critical part in ensuring product safety, compliance, and continuous improvement.

Key Responsibilities
  • Lead detailed failure investigations related to electro-mechanical systems and disposables products;
  • Analyze customer complaints, trends, and field data to determine potential issues and recommend product improvements as applicable;
  • Perform product testing, troubleshooting, and simulations to recreate reported problems and validate solutions;
  • Document investigation findings, analysis results in complaint handling system and / or reports;
  • Communicate findings and proposed solutions effectively to both technical and non-technical stakeholders;
  • As representative of Product Analysis group, interface and contribute within Software Problem Resolution process;
  • Contribute to Artificial Intelligence initiatives within Commercial Quality team.
Requirements
  • Bachelor's Degree;
  • Excellent communication skills (verbal and written);
  • Strong leadership skills;
  • Strong cross-functional ability;
  • Attention to detail focus;
  • Ability to handle multiple priority items at the same time;
  • Open and willing to take on new and differing tasks;
  • Familiarity with regulatory standards such as FDA 21 CFR 820 and ISO 13485.
Preferred Qualifications
  • Bachelor's Degree, in Electrical, Mechanical, Computer Science or Bio-Medical Engineering with 3 to 5 years of experience;
  • Prior hands-on experience in product testing / Electro-Mechanical Systems;
  • Software as a Medical Device (SaMD).

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.



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