GE Healthcare in Phoenix now has an opening for a Lead Quality Engineer with the following 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 total quality management system. Ensures quality and regulatory compliance while driving process effectiveness and efficiency.
- Ensures projects/products meets or exceeds customer expectations, product quality targets, and global regulatory requirements related to software.
- Champions 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.
- Utilizes 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.
They are looking for someone with the following qualifications:
- Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience).
- Minimum of 2 years of related work experience
- Experience in software design & development and/or understanding of product software development lifecycles, software design change and document change control, software process verification and validation methodologies, and servicing in a medical device environment.
- 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 expertise to effectively communicate within all levels of an organization around concepts of software design controls, Corrective & Preventive Action (CAPA), complaints, risk management, and product quality.
- Demonstrated oral and written communication skills.
- Demonstrated ability to analyze and resolve problems.
You can apply for this one here.