YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Project Engineer Quality Assurance and Configuration Management, are to: 

• Manage quality teams responsible for the daily support of Configuration Management functions;
• Lead and support process improvement initiatives associated with the Product Lifecycle Management (PLM) system and related business processes/procedures;
• Manage the development, execution, and reporting of validation activities required to maintain the PLM system and for associated feature enhancements / improvements;
• Lead and support the implementation of CM2 principles and practices into existing business processes within the Bayer Radiology organization;
• Lead / Support continuous improvement activities associated with change management practices across all Radiology manufacturing plants;
• Provide quality engineering support to develop, implement, and maintain quality engineering methodologies that meet Customer, Regulatory and Bayer requirements;
• Lead / Support Corrective Action/Preventive Actions and QIA’s to ensure effective closure of all actions per agreed-upon plans / schedules;
• Evaluate existing quality system and manufacturing processes and implementing projects that challenge the status quo and will lead to improved productivity and efficiency;
• Set functional and business objectives and measuring results;
• Integrate functional infrastructure (people, processes, tools) with business strategies and priorities;
• Create a culture that drives work efficiencies and high performance.

WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor’s degree in Engineering or related field with at least seven years of experience within a technical discipline;
• Proven ability to work collaboratively within a manufacturing support environment;
• Strong communication and interpersonal skills with ability to work well within a high-pressure environment;
• Experience with PLM and ERP systems;
• Proven ability to demonstrate analytical capabilities (including statistical analysis, analytical design tools, etc.);
• Proven basic knowledge in application of quality engineering and risk management tools such as statistics, Six Sigma, FMEA and problem-solving methodologies;
• Proven ability to demonstrate technical writing skills;

Preferred Qualifications:

• Master’s degree;
• Direct experience within the medical device industry (FDA Regulated);
• Experience with CM2 (Digital Thread and Digital Twin) concepts, principles, and best-practices;
• ICM/IpX CM2-C and/or ASQ CQE Certification;
• Knowledge of FDA Quality System Regulations and ISO Quality Standards;

#LI-US