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Sr. Quality Engineer - Indianola 

Sr. Quality Technician – Indianola, Pa

PURPOSE

The purpose of this role is 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.

This individual is responsible for deliverables and activities in support of the Product Analysis group within Bayer Radiology Devices.  Success in this role will be directly related to individual’s ability to effectively engage, learn, and deliver high quality output while working with multiple stakeholders and team members.

YOUR TASKS AND 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• 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).