Associate Specialist - Healthcare Quality jobs at Ge Healthcare in 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

Roles and Responsibilities:

• Reads and follows work procedures and schematics or receives verbal instructions regarding duties to be performed

• Performs manufacturing/assembly operations and various tasks following procedures, bills of materials, work instructions, and process aid sheets

• Maintains daily production output

• Follows all EHS and Quality policies and procedures

• May participate in quality control inspections

• Works with team lead, engineers, supervisors, and managers to improve quality and process efficiency

• Other duties as assigned, and may be asked to be included in quality activities, training sessions, and employee activity teams

• Comply with EHS regulations and policies

Qualifications/Requirements

• High School and ITI or 6 months of manufacturing experience

• 2 plus years of related manufacturing experience

• Ability to communicate, receive and understand instructions regarding duties to be performed

• Demonstrated ability to detail and quality-minded work habits

• Demonstrated ability to communicate with co-workers and leadership

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.

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