דרושים Sr Lead Specialist Quality - Healthcare ב-Ge Healthcare ב-הודו

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.

Essential Responsibilities

1. Provide technical and clinical leadership during sales process by demonstrating full range of product features including potential uses, product capabilities and benefits to customers as needed

3. Improve customer satisfaction and socket retention through continuing education on optimization of equipment utilization by customer

4. Support trade shows and professional conferences by performing product demonstration and promotion as well as customer training

6. Produce well-written post-training reports and provide regular feedback on customer satisfaction and needs.

Required Qualifications:

1. Required active professional clinical/technical certifications/registries necessary to scan live patients in a clinical setting

2. Demonstrated current basic clinical scanning proficiencies on current products/platforms

3. At least one of the following core experiences: Minimum of 5 years clinical/ technical experience following certification with demonstrated clinical/technical skill in specific areas or at least 3 years commercial applications/modality experience with demonstrated successes in high level customer interactions and sales scenarios

4. Proficiency in computer skills in Microsoft Office Suite products

5. Willingness to travel extensively within your specified geographic region as well as to nationwide sales meetings and tradeshows

6. To the extent you are applying for a position that requires you to operate a GE owned/leased, privately owned/leased or rental vehicle for company business, you must be willing to submit to a check of your driving record

7. Ability to communicate effectively using local language Quality Specific Goals

8.Master’s or bachelor's degree is mandatory

Preferred Qualifications:

1. Master’s or Bachelor's degree preferred in Cardiovascular Technology / Cathlab from a reputed University or Hospital. Experience in Electro Physiology (EP)will have an added advantage.

3. Strong presentation skills (public speaking and lecture experience desired)

4. Demonstrated ability to understand and present complex material in understandable terms

8. Self-motivated, willingness to take the initiative to identify opportunities for improvement and take actions to improve

10. Ability to multi-task effectively and manage multiple priorities at one time

11. Willingness to be flexible/adapt to changing work environments

12. Clinical experience in large hospital/university setting preferred

13. Advanced certification/registries desired

14. Five or more years of demonstrated clinical scanning skills in specific

15. Experience on all current GE products for which responsibilities cover

16. Experience within GE Clinical Applications or Clinical Marketing roles

17. Fluency in other relevant languages within territory

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

• 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

In this role, you will:
• Be responsible for defining, developing, and evolving software in a fast paced and agile development environment using the latest software development technologies and infrastructure
• Provide technical leadership to an agile team of 5-7
• Work with Product Line Leaders (PLLs) to understand product requirements & vision
• Translate requirements / vision into prioritized list of user stories and deliver to required timelines and quality standards
• Work with product line leaders and architects to develop multi generation software technology plans
• Drive increased efficiency across the teams, eliminating duplication, leveraging product and technology reuse
• Support process improvements which guide the development, sustaining & support activities
• Work cross functionally with other business departments to align activities and deliverables
• Drive world-class quality in the development and support of products
• Ensure team receives consistent messages and has clear understanding of business direction, strategy and results
• Engage subject matter experts in successful transfer of complex domain knowledge
• Apply principles of SDLC and methodologies like Lean/Agile/XP, CI, Software and Product Security, Scalability, Documentation Practices, refactoring and Testing Techniques
• Write code that meets standards and delivers desired functionality using the technology selected for the project
• Understand performance parameters and assess application performance
• Work on core data structures and algorithms and implement them using technology chosen
• Proactively share information across the team, to the right audience with the appropriate level of detail and timeliness

Education Qualification

Bachelor's Degree in Computer Science or “STEM” Majors (Science, Technology, Engineering and Math) with minimum years of experience 4years

Desired Characteristics

Technical Expertise:

•With minimum 4 years of software design & development experience working with cross-functional teams in an industry environment.
•Demonstrate proficiency in microservices with Java, spring boot programming on Linux environment.
•Work experience in Angular .

• Demonstrates the initiative to explore alternate technology and approaches to solving problems
• Skilled in breaking down problems, documenting problem statements and estimating efforts
• Demonstrates awareness about competitors and industry trends
• Has the ability to analyze impact of technology choices
• Ability to takes ownership of small and medium sized tasks and deliver while mentoring and helping team members
• Ensures understanding of issues and presents clear rationale. Able to speak to mutual needs and win-win solutions. Uses two-way communication to influence outcomes and ongoing results
• Identifies misalignments with goals, objectives, and work direction against the organizational strategy. Makes suggestions to course correct
• Continuously measures deliverables of self and team against scheduled commitments. Effectively balances different, competing objectives• Strong oral and written communication skills
• Strong interpersonal skills
• Effective team building and problem solving abilities
• Persists to completion, especially in the face of overwhelming odds and setbacks. Pushes self for results; pushes others for results through team spirit.

Inclusion and Diversity

• GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
• We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
• 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 would expect from an organization with global strength and scale, and you will 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.