Job Description Summary

This position is responsible for supporting manufacturing and/or engineering processes in accordance with documented procedures and practices. This role supports the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices. The role involves hands-on work in the areas of incoming and in process inspections CAPA, and internal audits, supporting manufacturing and distribution at our BK Medical site in State College, Pennsylvania.

BK Medical is committed to designing active imaging systems that help surgeons visualize anatomy and lesions, guide interventions, and navigate inside the human body. Our mission at BK is to change the standard of care in surgical interventions with real-time visual guidance, giving surgeons the information needed to immediately make critical decisions.

Now, BK Medical is advancing its mission with GE Healthcare. Together, we will reach more customers and continue to empower surgeons to make critical decisions that allow for better care, faster procedures, and reduced complications.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Role Responsibilities

• Create a Quality culture by driving compliance activities.

• Ensure ongoing patient safety, regulatory compliance, and enable commercial delivery of GE Healthcare products by providing total quality management system process support in accordance with documented procedures and practices.

• Responsible for implementing and continuously improving the quality management system in the area of production and process controls. Ensures quality and regulatory compliance while driving process effectiveness and efficiency.

• Assist with BK Medical QMS integration into the GE Healthcare Global QMS.

• Support the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting, and operating mechanisms.

• Performs internal audits, supports external audits, and promotes product and process improvements through root cause analysis and CAPA.

• Support risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.

Required Qualifications

• Bachelor's degree in Engineering or a related STEM degree from an accredited university or High School Diploma/Local equivalent (GED) with a Minimum of 3 years’ experience in a quality role.

• Proficient in Microsoft office (Word, Excel, PowerPoint).

• Strong oral and written communication skills.

Desired Characteristics

• Experience in a Regulated Industry and/or demonstrated understanding of Medical Device quality management systems, regulations, and international standards including but not limited to FDA 21 CFR 820, European Medical Device Regulation and ISO 13485.

• Demonstrated ability to analyze and resolve problems.

• Ability to document, plan, market, and execute programs. Established project management skills.

• Trained Internal Auditor.

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We will not sponsor individuals for employment visas, now or in the future, for this job opening.



Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.