דרושים Quality Training Plan Specialist ב-Ge Healthcare ב-India, Bengaluru

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

• GEHC ONLY 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.

• 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

• For roles outside of the USA- This role requires advanced experience in the Quality & Healthcare Quality. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).

• For roles in USA - Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)).

Desired Characteristics

• Experience in Quality Management System

• Manufacturing QMS Exposure

• Experience with ISO 13485

• Experience with FDA

• CAPA, process improvement

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

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

Methodology & Standards

• Develop a comprehensive understanding of the IIA standards, GEHC audit methodology, and related processes

• Develop, implement, communicate, and maintain internal standard operating procedures and guidelines covering all aspects of the internal audit process, including—but not limited to—risk assessment, planning, execution, and reporting.

• Based on input from the IA team, and benchmarking on current industry IA standards, review and recommend necessary enhancements to the internal audit methodology, policies, and procedures.

• Stay abreast on industry trends and emerging risks specific to the IA industry to adapt quality assurance processes to meet evolving demands.

Process Improvement & Digital Enablement

• Serve as a business analyst to understand, simplify, standardize, and automate existing processes related to engagement execution and/or reporting to key stakeholders, including the Audit Committee and GE HealthCare leadership and external stakeholders.

• Assist in the implementation and enhancement of audit tools, software, and data analytics to improve audit efficiency and effectiveness.

• Organize, maintain and drive enhancements for document management and collaboration tools and systems (e.g., Box and MS teams).

• Participate in ad-hoc projects as assigned (e.g., process improvement, QAIP, KPIs)

• Staying abreast on applicable new functionality for audit tools and help define strategy for pilot and adoption

Quality Assurance

• Support in the execution of quality assurance reviews of audit workpapers, findings, and reports for accuracy, clarity, and completeness while ensuring compliance with IIA industry standards and internal quality requirements.

• Support in the creation of training materials related to quality assurance methodologies and internal audit best practices.

Operational Reporting & Stakeholder Communication

• Assist on the monitoring of IA metrics (KPIs) and making periodic updates that align to the organization approved priorities and operations.

• Timely deliver ad-hoc requests such as creating and updating presentations and reports that are presented to Audit Committee, GE HealthCare leadership and external stakeholders.

Professional Experience/Success Profile

• Bachelor's degree in Business Administration, or a related fields (e.g., Quality Assurance, Project Management)

• Minimum of one year experience within Internal Audit, Operations or Business Management environment.

• Preferred understanding of quality control, process improvement and Internal Audit standards/methodologies (e.g., ISO, Lean, IIA,)

• Preferred understanding of project management methodologies (e.g., Agile, Waterfall)

• Exceptional attention to detail and ability to maintain high standards of quality in a fast-paced environment.

• Excellent listening, verbal, written and presentation skills to interact with internal teams and external stakeholders.

• Ability to work independently and collaboratively as part of a team.

• Strong organizational skills and ability to manage multiple tasks and priorities effectively

• Strong quantitative and qualitative analysis skills; ability to take large volumes of complex information and present it in a clear and concise manner; uses data and a cogent problem-solving methodology in decision making and impact assessment.

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

• Confidence to clearly articulate creative, practical solutions, even when dealing with demanding stakeholders or a high degree of ambiguity.

• Continuous learning mindset to keep up to date with industry developments and best practices in internal auditing.

• Working conditions: Is open to travel depending on the current state of affairs

Required Competencies

• Internal Control Knowledge: Ability to understand and assess the design, implementation, and operating effectiveness of internal controls.

• Project Management: Contributes to the planning and execution of planned audits.

• Root Cause Analysis: Ability to identify the root cause of an issue, demonstrating awareness of various root cause analysis techniques, such as the “5 why’s” test.

• Writing: Ability to document in a clear, concise, and logical manner process understanding (i.e., narratives/flow diagrams), risks, control descriptions, and test results (i.e., symptoms). Ability to analyze evidence and document findings in a structured and coherent way.

• Conflict Management Negotiation: Ability to handle difficult situations with diplomacy and tact and negotiate with management as appropriate to ensure key findings and follow-up actions are agreed upon.

• Influence: Ability to build trust and support with stakeholders

• Data Analysis and Business Intelligence Knowledge: General understanding of data and analytics techniques used in analyzing large volumes of data, ability to conduct simple data analysis using excel functions.

• Data Visualization: General understanding of data visualization techniques and their application

Required Qualifications

• A Bachelor's or Master’s degree in Accounting, Finance, Business Administration or "STEM" (Science, Technology, Engineering or Mathematics) Majors

• Two to five years of relevant internal audit or equivalent experience in industries such as Manufacturing, Medical Devices, Technology, Consulting or Financial Services.

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

Desired Characteristics

• CPA/CA, CFA, CIA or other professional certification is desired.

• Audit/risk management, data analytics experience or exposure is preferred.

• General knowledge of legal, regulatory and compliance requirements.

• Excellent listening, verbal, written and presentation communication skills.

• Lean Process orientation: Passion to help improve operations continuously

• Strong project management and organization skills.

• Problem solving skills that demonstrate logical and analytical thought processes.

• Know how to use technology and data to get things done.

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

Inclusion and Diversity

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