Job Description Summary

This role will be responsible for overall Quality Assurance activities at a medical device facility in Seattle, WA. They will establish a new GE HealthCare Digital facility, standing up the site to accommodate design and manufacturing of both software medical devices and non-medical devices. This role will be responsible to interact with external regulators, maintaining site certifications, driving continuous improvements in the area of quality and partnering with other Digital sites within GE HealthCare. They will interpret simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

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 global Digital product offerings. 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.
• Displays deep expertise within quality, providing professional or thought leadership. Defines and influences policy and ensures delivery within quality, linking with other functions of the organization. Interacts with external regulators, hosting inspections and representing the site from a quality perspective to leadership inside and outside of GE Healthcare.
• Will lead cross-functional teams or projects with moderate to high resource requirements, risk, and/or complexity. Presents business solutions to leaders in the area of quality.
• Communicates complex messages and negotiates mainly internally with others to adopt a different point of view. Influences peers to take action and may negotiate with external parties or customers.
• This role has a major influence on quality policy and operating guidelines impacting the site.
• Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders.
• Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.

Required Qualifications

• Minimum of Bachelor's Degree in Engineering, Computer Science or equivalent.
• Minimum 5 years’ experience in Quality Assurance / Regulatory Affairs.
• Minimum 3 years’ experience in software within a regulated industry.
• Practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC) in medical device or healthcare software development environment.
• Experience with Agile/Lean software development methods.
• Ability to effectively communicate technical information in English (both written and oral).

Desired Characteristics

• Strong leadership and communication skills.

• Previous project management experience is preferred.

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

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management.

• Demonstrated collaboration, negotiation & conflict resolution skills.

• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance.

• Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.

• Experience in a global working enviro