דרושים Quality Lead Specialist ב-Ge Healthcare ב-India, Bengaluru

Roles and Responsibilities

• Represent the design team and design control process from requirements development and design planning to design transfer.
• Lead development of requirements flow down, Architecture/System design and analysis, risk analysis, Cybersecurity analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction.
• Represent the design team in the development of verification and validation planning and execution ensuring quality targets are met. Involve with Verification Lead to quantify and benchmark product Quality and NFR.
• Ensure through detailed comparative analysis of solutions options that solutions are scalable, sustainable and fault tolerant.
• Work closely with cross functional teams across sites to manage technical program risks, integration risks and design tradeoffs.
• Work to ensure QMS compliance, DHF readiness & regulatory paperwork to enable CT programs towards achieving regulatory compliance and commercialization.
• Contribute towards product strategy, drive architecture decisions, and design solutions to resolve challenging customer problems.
• Be responsible for providing technical leadership and defining, developing, and evolving designs in a fast paced and agile development environment using the latest development technologies and infrastructure.

Required Qualifications

• A minimum of 15 years of technical experience along with established technology leadership credentials across disciplines and functions.
• Experience in working across Imaging modalities & handling LSD responsibilities.
• Experience in design & development of HW-Hardware /SW-Software /Systems designs. Preferably medical devices like CT, MR.
• Expert level skills in collaborating with different stakeholders, influencing decisions and an ability to take strategic view.
• Proven track record of successful problem definition, architecture/design rigor, technical decomposition, and project estimation.
• Analysis and development of design requirements at domain level, aligning architectural requirements with system development strategy and regulatory requirements.
• Demonstrated execution at meeting project goals while satisfying quality, performance, and schedule.
• Strong analytical and problem-solving skills, effectively evaluates information/data to make decisions, anticipates obstacles and develops plans to resolve.

Desired Characteristics:

• Able to work well with global teams, including time-zone flexibility.
• Skilled in providing oversight and mentoring team members. Ability to effectively delegate and govern work.

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities around a specific product, site or region. 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.

• Supports continuous product and process improvement through detailed failure analysis for nonconformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).

• Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.

• A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.

• Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.

• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

Required Qualifications

• This role requires advance experience in ISO 13485 and SDLC 62304 domain in a regulated industry (such as FDA, EUMDD/MDR)

• Demonstrated knowledge of Cybersecurity and Privacy.

• Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).

• Minimum Years of experience in the relevant industry - 5 to 10 Years or more

Desired Characteristics

• Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems.

• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to ISO 13485 and FDA 21 CFR 820.

total rewardsare 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.

Essential Responsibilities:

• Implement, and maintain IT systems and software for the Quality department to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH).

• Manage the investigation and resolution of IT-related issues, including system non-conformances and deviations.

• Translate unstructured or ambiguous requests into actionable technical requirements through problem decomposition and planning.

• Prioritize continuously in accordance with the understanding and validation of customer problems and needs.

• Stay updated with industry trends and regulatory changes to ensure compliance and best practices.

• Lead the implementation of new IT technologies and methodologies to enhance efficiency and accuracy.

• Own the short-term product roadmap and its integration into a larger application or strategic roadmap.

• Strong written and verbal communication skills.

Basic Qualifications:

• A Bachelor's Degree in Computer Science or “STEM” Majors (Science, Technology, Engineering and Math).

• A minimum of 6 years of relevant professional experience working in the Pharma or IT Industry including experience with Salesforce development activities.

• Proven experience in Salesforce development (Apex, Visualforce, Lightning Components, Flows).

• Hands-on experience with Salesforce architecture and integration patterns.

• Experience with Salesforce-based QMS platforms such as Trackwise Digital or Salesforce Health Cloud.

• Familiarity with Salesforce DevOps tools and CI/CD pipelines.

• Expert understanding of analysis & design and system architecture concepts.

• Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP), 21CFR Part 11, EU Annex 11. Familiarity with audit trails, electronic signatures, and validation documentation.

• Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues.

Desired Characteristics:

• Experience implementing Trackwise Digital on Salesforce platform.

• Understanding of QMS processes such as CAPA, Deviations, Change Control, and Audits.

• Ability to configure and customize Trackwise workflows and reports.

• Experience with Cloud technologies, Java, SQL, Integrations, API

• Experience working in remote / global teams.

• Ability to make technology choices based on experience and willingness to take calculated risks and experiment with newer technologies.

• Ability to develop partnership with stakeholders and develop an inclusive & collaborative environment.

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.

Roles and Responsibilities

• Skills in post market product surveillance to handle complaints and support efforts for regulatory reporting and establishing appropriate corrective and preventive actions for the safe and effective use of GE Healthcare (GEHC) products.

• Applies general knowledge of business developed through education or past experience. Understands how work of own team contributes to the area.

• Resolves issues using established procedures. Consults People Leader or more senior team members for issues outside of defined parameters.

• Collaborates with others to solve issues. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Exchanges technical information, asks questions and checks for understanding.

• Handles simple data entry work requiring face value check and correction.

Required Qualifications

• This role requires basic experience in the Quality & Product Surveillance. Knowledge level is comparable to a Bachelor's degree from an accredited university or college

Desired Characteristics

• Strong oral and written communication skills. Ability to document, plan, market, and execute programs.

total rewardsare 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

Key responsibilities include:

• Comply with Repair & Refurbishment requirement in Wipro GE Healthcare Repair & Refurbishment facility to achieve the output on daily basis and support the business growth.

• Responsible for meeting the PSI targets by working on the unit on daily basis and meet the daily output target.

• Good Technical knowledge on the ultrasound console & probes and capable of trouble shooting independently during repair & refurb process.

• Work with team and initiate Lean ideas (Kaizens) to continually improve on the process & productivity.

• Support team to Implement Good Manufacturing Practices, complying with all Quality regulations.

• Comply with ISO 13485, AERB, CDSCO and other Regulatory Requirements as needed

• Work with CFTs to achieve the desired output and meet the PSI numbers without miss.

• Adopt Lean and Advanced Manufacturing Practices for the day-to-day activities

• Co-ordinate with Global program team, Engineering, Process Engineer and QA to overcome the challenges during production.

• Support New Refurb products Program during Manufacturing validation activities & Compliance to regulations.

• Ensure EHS, QMS & Compliance in the Operations.

• Ability to work on transfer projects & to train team members to attain refurbishment capability.

Quality Specific Goals:

• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, Central Repair & Refurbishment Guidelines and applicable laws and regulations as they apply to this job type/positions

• Complete all planned Quality & Compliance training within the defined deadlines

• Identify and report any quality or compliance concerns and take immediate corrective action as required.

• Proficient knowledge, understanding and leadership for International Trade Compliance, identify, report and resolve any trade compliance issues.

Qualifications:

• Bachelor's Degree – Electrical & Electronics, Medical Electronics, Bio Medical Engineering or equivalent.

• 2-5 Years of experience working in Repair & Refurbishment activities & Global Supply chain management.

• Knowledge on Lean principles & Productivity mindset.

• Proven ability to meet deadlines in a fast-paced changing / challenging environment.

• Ability to work effectively in with cross-functional & global stakeholders.

Preferred Qualifications:

• Experience in Repair or Refurbishment or Supply Chain

• Proven ability to work on cross-functional, multi-cultural teams

• Creates energy to meet production targets and company goals through practical “hands-on” operational plans.

• Solid communication and analytical skills, including experience with communicating with others from different countries and cultures.
  

total rewardsare 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:

• Have awareness of SDLC and methodologies like Lean/Agile/XP, CI, Software and Product Security, Scalability, Documentation Practices, refactoring and Testing Techniques.

• Ability to write code that meets standards and delivers desired functionality using the technology selected for the project.

• Understand performance parameters and can assess application performance.

• Understand core data structures and algorithms and has the ability to implement them using language of choice.

• Write code that meets standards and delivers desired functionality using the technology selected for the project

Education Qualification

• Bachelor's Degree in Computer Science or “STEM” Majors (Science, Technology, Engineering and Math)

• minimum 0.6 years of experience

Desired Characteristics

• Comfortable in building features such as web services and Queries on existing tables.

• Aware of methods and practices such as Lean/Agile/XP, etc.

• Prior work experience in an agile environment, or introductory training on Lean/Agile. Aware of and able to apply continuous integration (CI).

• General understanding of the impacts of technology choice to the software development life cycle.

total rewardsare 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

• Vision and Strategy: Defining the overall vision and strategic direction for the platform, aligning it with business goals and user needs.

• Product Backlog Management: Creating, prioritizing, and maintaining the product backlog, which outlines the features, user stories, and tasks for platform development.

• Risk Management and QMS compliance: Drive Risk Management and QMS compliance between platform and products

• Prioritization and Decision-Making: Prioritizing features based on business value, user impact, and technical feasibility, making informed decisions about platform development.

• Stakeholder Management: Collaborating with various stakeholders, including users, business teams, and development teams, to gather feedback, manage expectations, and ensure alignment on platform goals.

• Communication and Collaboration: Facilitating communication between stakeholders and the development team, ensuring clear understanding of requirements, progress, and potential issues.

• Release Planning and Execution: Working with the development team to plan releases, track progress, and ensure timely delivery of platform features and updates.

• Performance Monitoring and Optimization: Tracking key metrics, analyzing user feedback, and identifying opportunities for continuous improvement and optimization of the platform.

• Conducts component and product integration. All activities that span multiple components and products and are concerned with how to integrate for maximum performance and operability. Manages product and systems requirements, specifications and flow down. Drives validation and verification activities for the overall product/system, including system level testing.

• Responsible for defining product requirements for the module / component / subcontractors and partners teams. Manages interface between components and execution organizations.

• Responsible for driving CTQ / Risk trades within the teams designing the components. Manages the overall product configuration and configuration control system.

• Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market

• Uses some judgment and has some ability to propose different solutions outside of set parameters to address more complicated manufacturing processes with technical variety and/or interdependent production cycles. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own teams to arrive at decisions.

• Acts 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.

Required Qualifications

• Bachelor's Degree in Computer Science or “STEM” Majors (Science, Technology, Engineering and Math) with a minimum of 8+ years of Advanced experience in the Engineering/Technology & Systems Engineering.

Skillsets

• Exposure in Product/system/feature ownership

• Defining Requirements

• Risks management

• Working exposure to SDLC and Quality Management System (QMS) compliance

• Software background from product development/medical domain is preferred

Desired Characteristics

• Excellent oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

Inclusion and Diversity

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.