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Company

GE HealthCare · 8 hours ago

Senior Director, Quality, Digital

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$161K/yr - $241K/yr

10+ years exp

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Growth Opportunities

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Responsibilities

Creates a Quality culture by driving compliance activities for the STO organization. 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.

People leader with senior level direct reports. Deep expertise within quality to drive compliance and continuous improvement in Digital Quality processes. Provides professional or thought leadership. Influences policy and ensures delivery within Digital Quality, linking with other functions of the organization.

Will lead functional teams or projects with moderate to high resource requirements, risk, and/or complexity to drive continuous improvement within the quality system. Presents business solutions to leaders in the area of quality including New Product Introductions, Recalls, CAPA, Quality Metrics, etc. 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 partners, vendors, or customers.

The role influences policy/operating guidelines impacting Digital Quality.

Uses high level of judgment to make decisions and handle complex tasks or problems that impact Quality. 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

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Quality AssuranceRegulatory AffairsAgile/Lean methodsMedical Device QMSFDA CFR 21 820ISO 13485Project ManagementRoot-cause analysisGlobal regulatory experienceExternal auditsInternal audits

Required

Minimum of Bachelor's Degree in Engineering, Computer Science or equivalent.

Minimum 10 years’ experience in Quality Assurance / Regulatory Affairs.

Minimum of 2 years’ experience as a people leader.

Experience with Agile/Lean software development methods.

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

Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.

Preferred

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.

Experience working and communicating directly with external medical device regulators.

Benefits

Medical

Dental

Vision

Paid time off

401(k) plan with employee and company contribution opportunities

Life

Disability

Accident insurance

Tuition reimbursement

Company

GE HealthCare

Glassdoor

4.2

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