Lead Specialist, Quality, Design Quality Engineer

GE HealthCare • Waukesha, WI

1d

About The Position

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. 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. Develops 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 way. Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is 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. Supports continuous product and process improvement through detailed failure analysis for non-conformances, investigations, develops and implements effective and compliant solutions for product and process corrections, retrospective and remediation action plans, and for corrective and preventative actions (CAPA process)

Requirements

• Bachelor's degree from an accredited university or college (OR a high school diploma / GED with at least 6 years of relevant work experience).
• At least 3 years of relevant experience in Quality Assurance in a regulated industry, e.g. Medical Devices.
• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
• Ability to communicate effectively in English (both written and oral)

Nice To Haves

• 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)

Responsibilities

• Creating a Quality culture by driving compliance activities around a specific product, site or region.
• Being responsible for the total quality management system for the business and driving Quality metrics.
• Ensuring quality and regulatory compliance while driving process effectiveness and efficiency.
• Representing 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.
• Executing functional policy/strategy.
• Communicating with direct colleagues and the business about design and related processes (design transfer, manufacturing, distribution, and service).
• Providing guidance to team members and explains complex information to others in straightforward way.
• Impacting projects, processes and procedures in own field.
• Operating with some autonomy, but is focused on execution of activities/processes.
• Utilizing technical expertise and judgement to solve problems.
• Leveraging technical skills and analytic thinking required to solve problems.
• Supporting continuous product and process improvement through detailed failure analysis for non-conformances, investigations, develops and implements effective and compliant solutions for product and process corrections, retrospective and remediation action plans, and for corrective and preventative actions (CAPA process)

Benefits

• GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.
• GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
• GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.
• Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level