Director, Quality & Regulatory, Digital Core Transformation position at GE HealthCare.| United States Of America

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GE HealthCare Director, Quality & Regulatory, Digital Core Transformation

Experience: 8-years

Pattern: full-time

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Waukesha....United States Of America

Job Description Summary Leads the Quality and Regulatory (Q&R) workstream for the Next Generation “Digital Core” transformation replacing key existing IT systems. Ensuring that all processes, data, and system capabilities enable compliant product realization and quality requirements. Partners with Q&R Process Owners (e.g., Design Controls, PPC/Product Hold, Supplier Quality, UDI) and other Functions/Program Leaders to help define requirements, validate solutions, and drive adoption while maintaining alignment to global Q&R expectations. 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 Articulate Q&R requirements across the IT tools that will be impacted by this transformation Articulate Q&R requirements across PLM capabilities and item types, translating regulatory and quality system needs into clear system and process requirements. Represent Q&R as a cross-functional change champion: communicate impacts, align stakeholders, and drive adoption of standard work within Q&R and across segments. Define the Validation strategy with the Global CSV team to ensure consistency and appropriate level of qualification required Manage the holistic plans for Q&R involvement and resource requirements Own Q&R defect and enhancement intake: clarify problem statements, prioritize with program leadership, and ensure timely resolution/closure with documented rationale. Assess program and product alignment impacts (process, data, configuration, and controls) and escalate decisions or risks to the right forums for resolution. Support planning, execution, and delivery of PLM implementation scope by defining Q&R workstream deliverables, milestones, and readiness criteria. Coordinate cross-functionally (including IT and external consultants) to track timing, execution, and metrics for Q&R-related requirements, testing, and deployment. Provide periodic status, risks, and decision needs to Q&R and program leadership; ensure Q&R resourcing and budget needs are surfaced and managed. Help establish operating mechanisms within the Q&R workstream and across functions (cadence, issue escalation, and decision tracking). Collaborate with engineering, IT, product management, operations, and leadership to manage conflicts and drive commonality and standardization across segments. Coordinate with Capability Leads and Segment Subject Matter Experts (SMEs) to define and formulate complete, testable requirements including Q&R-specific attributes and control points. Define standard formats for requirement classifications and attributes, and ensure requirements are captured consistently in the chosen tool(s). Optimize use of PTC off-the-shelf capabilities while ensuring compliant configuration and controlled changes for regulated use cases. Drive lean methodology into program plans by mapping current-state processes, surfacing pain points, and identifying efficiency gains without compromising compliance. Required Qualifications Bachelor’s degree and 8+ years of work experience – specifically in project / program management. Extensive experience in Quality and/or Regulatory roles within a regulated medical device and Drug environments. Strong working knowledge in multiple areas of the GE HealthCare Quality Systems and extensive use of these and/or related GE HealthCare IT Systems. Demonstrated leadership in cross-functional, enterprise-scale transformations (process, data, and/or business systems). Experience defining requirements and acceptance criteria and leading user testing/validation activities for enterprise systems impacting regulated processes. Desired Characteristics Familiarity with validation approaches for computerized systems and controlled configuration of enterprise tools used in regulated product realization. Strong program management, stakeholder management, and communication skills across global teams and leadership levels. Lean continuous improvement mindset with demonstrated ability to simplify processes, reduce variation, and drive adoption of standard work. Strong track record of digital transformation leadership in regulated environments (e.g., PLM, QMS, ERP/MES integrations), including process + data + people change. Deep understanding of quality systems and regulatory expectations and how they translate into scalable digital workflows (e.g., design controls, change management, post-market, complaints, risk management). Expertise in end-to-end product lifecycle thinking—connecting upstream design decisions to downstream manufacturing, service, and post-market outcomes. Ability to translate complex requirements into clear operating mechanisms: governance, decision rights, role clarity, escalation paths, and measurable outcomes. Data-driven mindset with experience defining and using leading indicators (quality, compliance, and process health) to steer priorities and investments. Strong executive presence with the ability to communicate succinctly to senior leaders and influence roadmap decisions. Skilled at building and sustaining cross-functional coalitions (e.g., Engineering, Regulatory, Quality, Supply Chain, Manufacturing, Service, Digital/IT). 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.

For U.S. based positions only, the pay range for this position is $142,400.00-$213,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information 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). 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. Relocation Assistance Provided: No

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Director, Quality & Regulatory, Digital Core Transformation job opportunity at GE HealthCare.

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