Quality Lead Specialist - Healthcare Quality

Job Description Summary

In this role as QA Lead Engineer you be will responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Management System practices, product specifications and applicable standards. You will collaborate within the areas of design, design transfer, manufacturing, distribution, and service.

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

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
• Developing in-depth knowledge of the product and processes. Uses prior experience and acquired expertise to execute functional policy/strategy.
• You will be an individual contributor, with demonstrated interpersonal skills. Communication with direct colleagues and the business about design and related processes (design transfer, manufacturing, distribution, and service). Provides guidance to team members and explains complex information to others in straightforward situations.
• Impacts projects, processes and procedures in own field. The role operates with some autonomy, within a team environment focused on execution of activities/processes. Activities require professional judgment, but may require more senior levels of guidance.
• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

​Required Qualifications

• Bachelor's degree from an accredited university/college or a minimum of 6 years of relevant work experience in Medical Devices, or similar regulated industry.

• Minimum of 3 years of experience working in a regulated industry.

• Ability to communicate effectively in English (both written and oral).

• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

​Desired Characteristics

• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

• Experience in Quality Assurance, Quality Engineering, Design Engineering or Manufacturing Engineering in a regulated industry.

• Demonstrated expertise to effectively communicate within different functions and different levels of the organization around QMS concepts including Design Controls, Production & Process Controls, Corrective & Preventive Action (CAPA), Risk Management and Product Quality.

• Demonstrated collaboration, negotiation, and conflict resolution skills.

• Experience performing internal audits and participating in external audits.

• Demonstrated understanding of design change, document change control and manufacturing/production process change control processes and methodologies.

• Ability to demonstrate analytical, problem solving & root-cause analysis skills along with experience leading and implementing change.

• Ability to handle tasks with competing priorities effectively.

• Strong technical aptitude (i.e., able to read & comprehend technical documentation & provide technical feedback)

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

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.