Qa Eng Manager Job at Baxter (São Paulo)

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Qa Eng Manager

This is where your creativity addresses challenges! As QA Engineering Lead you p...

Location

Brazil , São Paulo

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Pharmacists with postgraduate qualifications in Engineering and relevant experience in Quality, Validation, and regulated environments, or similar experience
7+ years of experience in Quality, Engineering, Validation, or Manufacturing within regulated medical device and/or pharmaceutical environments
Strong working knowledge of validation/CSV, change control, utilities and facilities qualification, and quality systems
Experience supporting regulatory inspections and audits

Job Responsibility

Provide QA oversight and governance for validation, change control, and lifecycle management of equipment, processes, utilities, facilities, and computerized systems across medical device and pharmaceutical operations, ensuring compliance with global regulatory standards (FDA, ISO, EU GMP, ICH, GAMP)
Review and approve validation, qualification, calibration, and change control documentation, ensuring systems remain in a state of control and risks to product quality, patient safety, and compliance are effectively managed
Support new product introductions, technology transfers, automation, digital solutions, and facility expansions, partnering with Engineering and Operations to embed Quality principles into continuous improvement initiatives
Oversee critical utilities, facilities, and metrology programs, ensuring systems are qualified, maintained, monitored, and inspection‑ready, with appropriate mitigation of deviations and out‑of‑tolerance conditions
Act as a key Quality partner during audits and inspections, drive standardization and simplification of QA Engineering processes, provide coaching and guidance to technical teams, and influence quality outcomes in a matrixed environment

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Principal Eng, V&V

You will be an integral part of the SW development – Verification & Validation t...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field
Minimum of 8 - 14 years of proven experience in testing WebApps, PC Apps
Proven Experience in formulating Test Strategies, V&V Plans & Procedures (Manual & Automation) for Web, Pc SW products that operate with AWS/Google/MS Azure Cloud
Hands-on Experience with Cucumber framework with Java script + Selenium, Postman, Test café framework with Java script, Robot framework with Python + Selenium (PREFERRED)
Programming Languages: Javascript, Python
(PREFERRED)
Experience in Development and Continuous Integration tools such as Azure DevOps a MUST
Behavior Driven Development and/or Test-Driven Development experience
Experience in working in Agile environment is a MUST
Experience in Generating Test Datasets for testing of WebApp flow

Job Responsibility

Effectively collaborate with cross-functional teams, including business analysts/product owners, developers, QA, and other stakeholders, to understand the requirements, analyze failures and identify root causes
Directly responsible for implementing the test plans and authoring test procedures for WebApp frontend, Middleware and Back-end components including external interface testing
Implement Test Automation plans along with Test team, by applying techniques such as BDD, TDD and develop modular test suites, test data, reusable test scripts/libraries using state-of-the-art frameworks tools & technologies
Collaborate with multi-site V&V and DevOps teams to support integration of test infrastructure into DevOps pipelines and configuration management
Directly responsible for manual and exploratory testing to ensure complete coverage of SW modules
Execute and derive Verification & Validation Results, traceability matrices and appropriate quality metrics
Participate in sprint planning, task scheduling and prioritization of test efforts in alignment with Agile methodologies
Collaborate with team members to identify/implement test techniques that are effective and efficient in meeting organizational goals for product quality, timeliness, and regulatory compliance
Execute projects with minimal guidance/ supervision and drive the application of principles of SDLC and methodologies/processes such as IEC 62304, Lean, Agile, CI to deliver and maintain design outputs including test script, test data, results and documentation that meet applicable statutory and regulatory requirements
Provide input for continuous improvement activities by identifying and appropriately escalating process and product quality gaps

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Sr Eng, Systems

Baxter’s Front Line Care business products expand Diagnosis & Therapies to bette...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Experience in Requirement analysis, flow down, risk assessment, system thinking
Develop or refine user/product requirements and work with developers for their implementation and testing
Involvement in the system and medical risk management activities for our products and ensuring the safety of the product for patients and caregivers
Resolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, 5 Whys, Pareto charts, etc.
Experience in electromechanical hardware development, preferably medical devices or other highly regulated products such as military hardware
Ability to generate alternative solutions to problems or processes
Simulate therapy algorithms using modeling & simulation software like Matlab/Simulink. Ability to apply engineering concepts to electro-mechanical systems with software, their functionality, connectivity, and usability aspects
Strong interpersonal skills with the ability to work collaboratively with others in a team environment
Excellent background in fundamentals of circuit design and analysis
Experience with industry leading software tools for schematic entry and PCB layout design

Job Responsibility

Makes technical contribution in Systems & Electronics engineering activities by providing technical contribution within an area of expertise to contribute towards requirement, analysis, detailed design and verification activities for an assigned product, project or solution
Support the development of creative solutions to challenging issues associated with the design, development, and sustaining engineering for our new and existing product portfolio
Prepare Requirements, Traceability Matrices, and final reports and ensure good documentation and DFx practices are followed
Identifies technical problems, provides innovative, creative solutions
shares technical knowledge with team
Understanding of business, market, industry and competitive knowledge & integrating into technical solutions that can be readily adapted to changes in technology and/or clinical use
Generates alternatives and takes reasonable risks while solving technical problems
Work and collaborate closely with Project Manager & Team leads to define and solve engineering changes/problems to make products that meet all performance and functional criteria within required project schedule, with minimum guidance
Participate in design/change reviews with the Sustaining Team and Engineering Change Board – justify design detail and collaborate with other team members
Completes detailed, high quality technical documentation of product designs through the generation and maintenance of design requirement specifications, engineering prints, material specifications and bills-of-materials

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Sr Eng, Systems

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Experience in Requirement analysis, flow down, risk assessment, system thinking
Develop or refine user/product requirements and work with developers for their implementation and testing
Involvement in the system and medical risk management activities for our products and ensuring the safety of the product for patients and caregivers
Resolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, 5 Whys, Pareto charts, etc.
Experience in electromechanical hardware development, preferably medical devices or other highly regulated products such as military hardware
Ability to generate alternative solutions to problems or processes
Simulate therapy algorithms using modeling & simulation software like Matlab/Simulink. Ability to apply engineering concepts to electro-mechanical systems with software, their functionality, connectivity, and usability aspects
Strong interpersonal skills with the ability to work collaboratively with others in a team environment
Excellent background in fundamentals of circuit design and analysis
Experience with industry leading software tools for schematic entry and PCB layout design

Job Responsibility

Identifies technical problems, provides innovative, creative solutions
shares technical knowledge with team
Understanding of business, market, industry and competitive knowledge & integrating into technical solutions that can be readily adapted to changes in technology and/or clinical use
Generates alternatives and takes reasonable risks while solving technical problems
Work and collaborate closely with Project Manager & Team leads to define and solve engineering changes/problems to make products that meet all performance and functional criteria within required project schedule, with minimum guidance
Participate in design/change reviews with the Sustaining Team and Engineering Change Board – justify design detail and collaborate with other team members
Completes detailed, high quality technical documentation of product designs through the generation and maintenance of design requirement specifications, engineering prints, material specifications and bills-of-materials
Uses existing engineering tools and best practices to report and track product and process metrics
Challenges project teams and established work processes and proactively finds creative methods to reach desired performance levels
Informs others proactively about developments or issues that affect their work, and their ability to meet commitments

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Principal Eng, Test

As a Sr SDET for software, you will be an integral part of the SW development – ...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field
Minimum of 7-12 years of proven experience in testing WebApps, PC Apps
Healthcare experience is a plus
Proven Experience in formulating Test Strategies, V&V Plans & Procedures (Manual & Automation) for Web, Pc SW products that operate with AWS/Google/MS Azure Cloud
Experience in Testing Mobile Apps is a plus
Hands-on Experience with one or more of the frameworks: Cucumber framework with Java script + Selenium, Postman
Test café framework with Java script (PREFERRED)
Robot framework with Python + Selenium (PREFERRED)
Programming Languages: Javascript, Python
Additional Experience with C, C++ is a plus

Job Responsibility

Effectively collaborate with cross-functional teams, including business analysts/product owners, developers, QA, and other stakeholders, to understand the requirements, analyze failures and identify root causes
Directly responsible for implementing the test plans and authoring test procedures for WebApp frontend, Middleware and Back-end components including external interface testing
Implement Test Automation plans along with Test team, by applying techniques such as BDD, TDD and develop modular test suites, test data, reusable test scripts/libraries using state-of-the-art frameworks tools & technologies
Collaborate with multi-site V&V and DevOps teams to support integration of test infrastructure into DevOps pipelines and configuration management
Directly responsible for manual and exploratory testing to ensure complete coverage of SW modules
Execute and derive Verification & Validation Results, traceability matrices and appropriate quality metrics
Participate in sprint planning, task scheduling and prioritization of test efforts in alignment with Agile methodologies
Collaborate with team members to identify/implement test techniques that are effective and efficient in meeting organizational goals for product quality, timeliness, and regulatory compliance
Execute projects with minimal guidance/ supervision and drive the application of principles of SDLC and methodologies/processes such as IEC 62304, Lean, Agile, CI to deliver and maintain design outputs including test script, test data, results and documentation that meet applicable statutory and regulatory requirements
Provide input for continuous improvement activities by identifying and appropriately escalating process and product quality gaps

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Principal Eng, Software

This is where your work makes a difference. At Baxter, we believe every person—r...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

A Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field is required
Must have a minimum of 12-15 years of proven experience in web development
Healthcare experience is a plus
Hands on working knowledge in Cloud technologies (AWS, Azure)
Experience in mobile App development using Kotlin is a plus
Knowledge of Mobile App development and Cybersecurity technology will be an advantage
Proven experience creating solutions in PAAS environment on MS AZURE (preferred) / AWS/ Google Cloud environments
Programming Languages: C#, Javascript
Additional Experience with C++, Python is a plus
Extensive experience in .NET Framework and .NET Core

Job Responsibility

Follow documented procedures for all activities related to the Bardy Dx Quality System
Complete other duties as assigned
Directly responsible for the creating, designing, and maintaining cloud-based Web Applications and solutions to contribute towards new product development programs, sustenance activities and field issue resolution efforts
Effectively collaborate with cross-functional teams, including business analysts/product owners, developers, QA, and other stakeholders, to prepare, analyze, and understand the requirements
Directly responsible for identifying, applying state-of-the-art architectural patterns and design techniques to translate requirements into modular, scalable software and Web solutions, that meet user needs
Lead projects with minimal guidance/ supervision and drive the application of principles of SDLC and methodologies/processes such as IEC 62304, Lean, Agile, CI to deliver and maintain design outputs including code and documentation that meet applicable statutory and regulatory requirements
Provide guidance for development and testing teams to ensure defect free operation and drive code quality, security reviews to meet industry-wide quality & security standards
Collaborate with the project management teams to prioritize and deliver high quality and timely deliverables
Lead sprint planning, daily standups, demos, retrospectives and software design meetings
Owns and drives continuous improvement activities by identifying and appropriately escalating process and product quality gaps

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Principal Eng, Software

This is where new knowledge is discovered. Baxter’s Research and Development tea...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field
Minimum of 12-15 years of proven experience in web development
Hands on working knowledge in Cloud technologies (AWS, Azure)
Proven experience creating solutions in PAAS environment on MS AZURE (preferred)/AWS/Google Cloud environments
Programming Languages: C#, Javascript
Extensive experience in .NET Framework and .NET Core
Solid understanding of database technologies including Azure SQL DB/MS SQL
Working knowledge on Windows/Linux Server/Backend Components
Enterprise Integration: Design patterns for enterprise integration REST and Microservices
Experience in Development and Continuous Integration tools such as Azure DevOps

Job Responsibility

Follow documented procedures for all activities related to the Bardy Dx Quality System
Complete other duties as assigned
Directly responsible for the creating, designing, and maintaining cloud-based Web Applications and solutions to contribute towards new product development programs, sustenance activities and field issue resolution efforts
Effectively collaborate with cross-functional teams, including business analysts/product owners, developers, QA, and other stakeholders, to prepare, analyze, and understand the requirements
Directly responsible for identifying, applying state-of-the-art architectural patterns and design techniques to translate requirements into modular, scalable software and Web solutions, that meet user needs
Lead projects with minimal guidance/supervision and drive the application of principles of SDLC and methodologies/processes such as IEC 62304, Lean, Agile, CI to deliver and maintain design outputs including code and documentation that meet applicable statutory and regulatory requirements
Provide guidance for development and testing teams to ensure defect free operation and drive code quality, security reviews to meet industry-wide quality & security standards
Collaborate with the project management teams to prioritize and deliver high quality and timely deliverables
Lead sprint planning, daily standups, demos, retrospectives and software design meetings
Owns and drives continuous improvement activities by identifying and appropriately escalating process and product quality gaps

What we offer

Support for Parents
Continuing Education/Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Eng II, Advanced Surgery

This individual will be part of and provide support to the Support to Sustaining...

Location

India , Bengaluru

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Bio Medical /Mechanical Engineering or Equivalent
3+ years of experience in Sustaining Engineering projects
Excellent Verbal and Written skills in English
Excellent communication and presentation skill
Should be able to communicate effectively in a multi-cultural working environment
Strong Collaboration and interpersonal skills
Ability to co-ordinate with stakeholders of cross functional and Leadership Team
Excellent critical thinking and problem-solving skills and application of methods and tools
Independent worker as well as Team Player with strong execution abilities to complete projects within timeline
Knowledge of US & EU Regulations and medical device standards – ISO 13485, ISO 14971

Job Responsibility

Provide support to the Support to Sustaining Engineering team
Be part of the SPO team that leads the efforts in Change Management and related activities
Ensure successful initiation, planning and completion of small or complex project through monitoring, tracking and analyzing project activities and metrics
Serve as SPOC for team and collaborate with Project stakeholders
Handling of Change controls/Change Management activities
Ensure implementation of quality processes including Change control and design control activities
Preparation and review of project related documents, protocols and reports as required
Assist Project Manager in reviews and ensure project complies with QA processes and adhering to defined timelines
Review Changes to existing process and products and drive them via change control and ensure timely completion/closure
Work with Global team, Co-ordinate with different stakeholders (PDO, QA, RA, etc) to understand their requirements, prioritize the tasks & ensure the completion

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

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