דרושים Staff Enterprise Application Engineer Multiple Positions ב-Ge Healthcare ב-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

In this role, you will:
• Lead and coordinate the domain technical and business discussions relative to future architecture direction across the product portfolio or product line.
• Analyze design and develop a roadmap and implementation plan based upon a current vs. future state in a cohesive architecture viewpoint.
• Review and/or analyze and develop architectural requirements at domain level within product portfolio or team.
• Participate in the enterprise architecture domain governance model.
• Contribute to the development of software and data delivery platforms with reusable components that can be orchestrated together into different methods.
• Lead the research and evaluation of emerging technology, industry and market trends to assist in project development and/or operational support actives.

Required Qualifications

• Bachelor's Degree in Computer Science or “STEM” Majors (Science, Technology, Engineering and Math)
• 8 years of software architectural design experience

Desired Characteristics
• Ability to consult customer on alignment of outcomes and desired technical solutions at an enterprise level
• Ability to Analyze, design, and develop a software solution roadmap and implementation plan based upon a current vs. future state of the business.
• Working knowledge of configuration choices and related cost implications; Experience with complex solution configurations.
• Knowledgeable of full range of solution catalog within a business unit and able to discuss overall solution at depth.
• Experience sustaining operational stability through various life cycle phases (planning, implementation, steady state, de-commissioning); Ability to provision and budget via capital and operating.
• Able to lead early stage customer interactions; Guide customers as they develop confidence and comfort with approaches, and integrate with their legacy tech investments.Business Acumen:
• Adept at navigating the organizational matrix; understanding people's roles, can foresee obstacles, identify workarounds, leverage resources and rally teammates.
• Understand how internal and/or external business model works and facilitate active customer engagement
• Able to articulate the value of what is most important to the business/customer to achieve outcomes
• Able to produce functional area information in sufficient detail for cross-functional teams to utilize, using presentation and storytelling concepts.
• Possess extensive knowledge of full solution catalog within a business unit and proficiency in discussing each area at an advanced level.
• Six Sigma Green Belt Certification or equivalent quality certificationLeadership:
• Demonstrated working knowledge of internal organization
• Foresee obstacles, identify workarounds, leverage resources, rally teammates.
• Demonstrated ability to work with and/or lead blended teams, including 3rd party partners and customer personnel.
• Demonstrated Change Management /Acceleration capabilities
• Strong interpersonal skills, including creativity and curiosity with ability to effectively communicate and influence across all organizational levels
• Proven analytical and problem resolution skills
• Ability to influence and build consensus with other Information Technology (IT) teams and leadership

Note:
To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.This Job Description is intended to provide a high level guide to the role. However, it is not intended to amend or otherwise restrict/expand the duties required from each individual employee as set out in their respective employment contract and/or as otherwise agreed between an employee and their manager.

Qualifications / Requirements:

Bachelor’s degree or equivalent in Computer Science, Sciences, Technology, Engineering, Math or related. Six (6) years of experience in software applications development, business systems support, or a combination thereof. Employer will accept a Master's degree or equivalent in Computer Science, Sciences, Technology, Engineering, Math or related and four (4) years of experience in software applications development, business systems support, or a combination thereof in lieu of a Bachelor's degree or equivalent and six (6) years of experience as described above. Work experience to include: Experience in ERP, for example PeopleSoft or Oracle Apps, and modules such as Order Management, Production, Inventory, Contracts, Saas Billing; Domain experience and functional knowledge on various business processes such as Order to Remittance (OTR), Enterprise Service Automation (ESA) and Electronic Delivery, Node locked and Floating Licensing; Experience leading and managing support of whole business fulfilment process spanning across multiple enterprise applications and tools; Experience solving challenging issues in high pressure environment including analyzing, troubleshooting and coordinating the session for application issues leveraging different support team and other internal supporting organizations; Experience using SOAP and GraphicQL or Rest API's and GraphicQL; Experience with middleware technologies such as BOOMI or API Gateways; Experience in Data modeling, ETL (Extract, Transform, Load) processes, and data mapping using various data formats and standards (such as XML or JSON); Experience in security protocols, encryption, and best practices in ensuring secure integration across systems; Experience developing chatbots or AI-driven applications with GPT models or similar AI frameworks used for chatbot development; Programming languages such as Python which are commonly used in AI and Chatbot development; Cloud solution approaches from a technical (infrastructure), service management, financial and sourcing perspective; Writing SQL queries; Experience in database concepts (such as indexing, transactions, stored procedures, triggers, views and normalizations) and optimizing SQL queries for better performance and query execution plans; Experience working on user-friendly analytics platform (such as Spotfire or Tableau) to design intuitive and user friendly dashboards using these tools by exporting eDelivery data; Fundamental principles of data visualization (such as choosing appropriate chart types, color schemes, layouts and visual elements) and interpreting visualized data accurately to communicate insights to various stakeholders; Using advanced visualization features such as scripting custom expressions and incorporating statistical models into visualizations.

Salary for this position is $148,949/yr