Lead Specialist Quality Management Systems Digital jobs at Ge Healthcare in United States, Chicago

Roles and Responsibilities

• Foster a Quality culture by driving compliance to global and local policies, procedures and work instructions included in the Chicago Site Quality Plan

• Support the Chicago Manufacturing Site by implementing and overseeing robust production and process controls

• Collaborate with cross functional stakeholders to aid continuous improvement (lean) projects

• Conducts internal audits of the QMS to ensure high level of compliance

• Supports external audits from regulators by preparing information, assisting during the audit execution and follow up of post audit activities

• Performs a broad variety of QMS & compliance tasks as result of continual improvement initiatives or as assigned by supervisor

• Champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting, and operating mechanisms for QMS processes

• Support the Chicago Quality team by following up on production and process controls related project deliverables

• Explains information and influences team members to consensus around total quality and continuous improvement.

• Employs risk based thinking approach across QMS processes.

Required Qualifications

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience) in computer, science or engineering field.

• Minimum of 2 years of work experience in quality assurance or quality engineering in a regulated industry.

• 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.

Desired Characteristics

• Good understanding and knowledge of local and global Medical Device QMS regulations and standards such as but not limited to FDA 21 CFR 820, EN ISO 13485, EU MDR.
• Experience with Software as Medical Device (SaMD) and Medical Device Manufacturing (GMP) is a plus.
• Demonstrated expertise to effectively communicate within all levels of an organization around concepts like NC, Corrective & Preventive Action (CAPA), Personnel training, Document & Record control and product quality.
• Knowledge of Risk Management standards/practices.
• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Strong time management, prioritization and organization skills .

Ourare 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.

Roles and Responsibilities

• Foster a Quality culture by driving compliance to global and local policies, procedures and work instructions included in the Chicago Site Quality Plan

• Support the Chicago Non-conforming (NC), Investigation & CAPA processes by providing coaching on conducting and documenting root cause analysis, product/process impact & risk assessments, defining corrections, corrective & preventive actions, and effectiveness checks

• Collaborates with the implementation and monitoring of global and local QMS documentation changes as well as the Chicago site Training program

• Conducts internal audits of the QMS to ensure high level of compliance

• Supports external audits from regulators by preparing information, assisting during the audit execution and follow up of post audit activities

• Performs a broad variety of QMS & compliance tasks as result of continual improvement initiatives or as assigned by supervisor

• Champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting, and operating mechanisms for QMS processes

• Support the Chicago Quality team by following up on QMS related projects deliverables

• Explains information and influences team members to consensus around total quality and continuous improvement.

• Employs risk based thinking approach across QMS processes.

Required Qualifications

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience) in computer, science or engineering field.

• Minimum of 2 years of work experience in quality assurance or quality engineering in a medical device organization.

• 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.

Desired Characteristics

• Good understanding and knowledge of local and global Medical Device QMS regulations and standards such as but not limited to FDA 21 CFR 820, EN ISO 13485, EU MDR.
• Experience with Software as Medical Device (SaMD) is a plus.
• Demonstrated expertise to effectively communicate within all levels of an organization around concepts like NC, Corrective & Preventive Action (CAPA), Personnel training, Document & Record control and product quality.
• Knowledge of Risk Management standards/practices.
• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Strong time management, prioritization and organization skills .

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.

• Provide clinical support for the development of gadolinium and iodinated Contrast Media.

• Apply knowledge of clinical MR, CT, IR, and Cath Lab to support all key internal and external stakeholders

• Assist with trials, implementation, training, relative to iodinated and gadolinium Contrast Media.

• Demonstrate effective presentation skills in diverse settings from one-on-one to formal large group situations, in-person and virtually

• Covers IL, WI, MN, ND, SD, IA, NE, KS, and MO

• Experience in MRI, CT, X-Ray, Cath Lab, or Interventional Radiology

• At least 5 yrs. of experience in the medical industry

• Ability to work independently, as well as within a team

• Strong ability to work cross-functionally while balancing multiple priorities

• Customer contact experience in various clinical situations

• Ability to travel as needed within defined territory

• Demonstrate strong organizational, written, and verbal communication skills

• Bachelors or 5 years equivalent experience

• Contrast Media application experience

• MRI, X-ray, CT, or Nuclear Medicine experience

• Clinical credentials

• Develop and maintain fully loaded P&L models for the total USCAN P&L at business, regional, and sub-modality levels for use in reporting, planning, and financial analysis for GEHC and overall GE.

• Drive the adoption of standard work, automation, and digitalization of key financial reports, operational drivers, and key analyses.

• Partner with Regional Finance Managers, FP&A teams, and operational owners on estimates and key drivers.

• Support planning and strategy discussions for the total USCAN business.

• Drive closing and reporting communication (quarter close, M reviews, MOR reviews) for all USCAN finance.

• Own several HQ functions, including program spend, headcount, and investments.

• Bachelor's degree in Economics, Finance, or Accounting from an accredited university or college.

• 5+ years of experience in areas such as accounting, budgeting, financial analysis, reporting, forecasting, compliance management, and team leadership, with at least two years of FP&A experience, OR a graduate of GE HealthCare’s Financial Management Program with 2+ years of FP&A experience.

• Strong analytical skills: able to clearly link financial results to operational performance drivers.

• Clear thinking and problem-solving: successfully led projects/process improvements within operations/finance functions; able to quickly grasp new ideas.

• Adaptable and flexible: open to change in response to new information, different or unexpected circumstances, and able to work in ambiguous situations.

• Solid PC skills: experience with financial systems/applications (e.g., Oracle, Hyperion, Business Objects), strong Excel skills in data compilation and aggregation (e.g., Pivot Tables, VLOOKUP, and Macros), and experience/interest in data visualization tools (Power BI).

• Experience working in a global business environment with a sound understanding of global processes and transactional flows.

• Excellent communication skills: experience working across multiple levels (including executive level), functions, and regions.

• Experience working in a matrixed environment.

Ourare 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.

• Lead Financial Analyst for the GE Healthcare Corporate functions. Key business partner for Functional leaders to provide insight on how to improve operations and business profitability

• Lead the business estimating and budgeting processes - annual budget, monthly forecasts at each level of the organization. Define KPIs to measure the performance of Corporate Functions.

• Analyze the performance and propose action plans to improve profitability as well as corrective action plans as needed.

• Utilize in-depth knowledge of organization, processes and analytical thinking to execute improvements in policies and strategy.

• Act as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information, developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.

• Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).

• Use judgment and have the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Have the ability to prioritize information for data analysis. Use technical experience and analytical thinking. Use multiple internal and limited external sources outside of own team to arrive at decisions.

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Finance function)

• 4 years FP&A experience

• Demonstrated ability to analyze and resolve problems. Ability to document, plan, and execute programs.

• Able to clearly link financial results to operational performance drivers, generate alternatives and drive positive change

• Ability to operate in a fast-paced environment

• Results-oriented mindset and acts proactively

• Proficient in Microsoft Excel, Power BI

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.

A key priority for this role will beto execute data analytics and automation projectsAudit Specialist - Data Analytics and Automationwill support in various aspects of IA processes such as risk assessments, audit planning and execution, issue management and special department initiatives for continuous improvement.

• Leverages and applies advanced data concepts, tools, and programming techniques (e.g., Teradata, and/or comparable platforms) to perform, extract, transform, load (ETL) and analyze activities, and proactively shares knowledge with team members.

• Contributes to the overall automation of audit bot design, build, testing/defect resolution, and change control management procedures.

• Partners with enterprise data lake and automation teams to ensure the accuracy and completeness of bot designs, and quality of bot output.

• Contributing to the planning and completion of high-quality engagement deliverables on time and on budget.

• Supports the extraction, manipulation, visualization, and analysis of data that support the internal audit lifecycle.

• Operationalizes analytical models (e.g., regression, simulation, statistical, etc.) for direct application to audit scope areas for the identification of outliers, trends and/or projections, where appropriate.

• With oversight from Managers and other senior team members,identify trends, anomalies, and areas for improvement in business operations.

• Assisting in the design and layout of analysis and in writing accurate reports to depict findings, contributing to the development of conclusions and recommendations.

• Establishing credibility and developing relationships with key client stakeholders including front-line staff and mid-level managers.

• Facilitates data-driven discussions with IA team members and provides recommendations for streamlining audit finding analysis during on-going audits and in the planning of future audits.

• Stays current on data analytics trends (e.g., new tools, statistical methods, visualization techniques), relevant business risks across GE HealthCare Business Units, as well as emerging industry technologies that impact how and where data and automation can be used on audits and in support of key company controls (e.g., Artificial Intelligence (AI), Blockchain, RPA).

• Embrace an equitable and inclusive environment where people can bring their full selves to work and unlock their greatest potential and contributions to the team.

• Data Literacy

  • Data Science and AI Knowledge: Understands the principles of data science and can execute data science and AI projects.

  • Data Source Identification: Is aware of data sources to use for data analytics work and understands how the data sources align to key risks.

  • Communication of Data and Analytics: Understands what constitutes good data communication skills and can clearly explain data analysis results.

• Communication & Relationship Management

  • Relationship Management/ Business Partnerships: Cultivates and maintains extensive informal networks and can establish and maintain good working relationships with all staff at all levels of the organization.

• A Bachelor’s degree or Master’s degree in Data Analytics, Mathematics, Computer Science or other technical field.

• 2 years of data analytics development and deployment. Experience in an Internal Audit or Cyber Security data analytics capacity, preferred.

• Proficiency in Python or R for data analysis and automation.

• Microsoft Certified Azure Data Scientist Associate, aCAP, CCA Data Analyst, CISA, CRISC, or similar certifications/designations.

• Proficiency in SQL for querying and managing data.

• Advanced knowledge of generative AI principles and their application in data analysis.

• Strong understanding of AI principles, including machine learning, deep learning, and foundational models such as neural networks and natural language processing (NLP). Capable of leveraging AI technologies to enhance data analytics and automation processes within internal audit functions.

• Advanced understanding of GitHub for version control and collaborative code management.

• Strong problem-solving skills that demonstrate logical and analytical thought processes with high attention to detail and accuracy.

• Proficiency in data mining, analysis, and visualization tools, along with a strong understanding of data integrity issues.

• Experience with data visualization and dashboard development in PowerBI or similar.

• Knowledge of current data analytics tools, techniques, and landscape, as well as a dedicated and self-driven desire to keep abreast of the latest data analytics techniques.

• Experience with business fraud or internal audit analytics and investigation techniques.

• Ability to work collaboratively with minimal supervision as part of a multi-disciplinary team.

• Strong communications skills (verbal and written) with both technical and non-technical audiences.

• Ability to flex personal style according to the context of a situation to drive engagement with all stakeholders.

• Ability to travel internationally and domestically approximately 5-10%.

Ourare 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.