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GE HealthCare · 1 day ago

Associate Director, Quality Site Leader, PNW Site

Bellevue, WA

Full-time

Onsite

Lead/Staff, Director/Executive

$122K/yr - $184K/yr

5+ years exp

GE HealthCare is a leading global medical technology and digital solutions innovator. The Associate Director, Quality Site Leader will be responsible for overseeing quality assurance activities at the Bellevue office, ensuring compliance with regulations and driving continuous improvements in quality processes.

AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical

Growth Opportunities

No H1B

Responsibilities

Creates a Quality culture by driving compliance activities around Digital product offerings. This includes being responsible for the quality management system for the site 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

Qualification

Quality AssuranceRegulatory AffairsSoftware Development LifecycleMedical Device QMSAgile/Lean methodsArtificial IntelligenceAnalytical SkillsProject ManagementLeadership SkillsCommunication SkillsNegotiation SkillsConflict Resolution

Required

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)

Preferred

Experience in the development of (Artificial Intelligence) AI enabled products

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 environment

Experience leading and implementing change. Experience performing internal audits and participating in external audits

Exceptional analytical, problem solving & root-cause analysis skills. Ability to multi-task & handle tasks with competing priorities effectively. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators

Benefits

Medical

Dental

Vision

Paid time off

A 401(k) plan with employee and company contribution opportunities

Life

Disability

Accident insurance

Tuition reimbursement

Company

GE HealthCare

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GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees