Sr. Quality Engineer Job at Realign (Toronto)

Sr. Quality Engineer

We are currently seeking a Sr. Quality Engineer to join our team in Parsipanny, ...

Location

United States , Parsipanny

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

6+ years of experience in test automation: Selenium/Java/Cucumber/REST Assured (both UI and API automation) or Selenium/.NET/Cucumber/REST Sharp
5+ years of experience in software testing and writing automation scripts using Java, C#, and/or JavaScript/TypeScript
5+ years of experience in designing functional and end-to-end test cases to ensure comprehensive test coverage
At least 4+ year of experience using a test automation tool like Selenium/Cucumber/ Java or Selenium/C#.net/Spec Flow/Rest assured or similar frameworks
3+ years of experience in test automation with AMQ,WMQ, Kafka, Couchbase and GCPS
3+ years of experience with OpenShift and Kubernetes
Knowledge in Behavior-Driven Design (BDD) principles and the use of Cucumber (or similar) testing frameworks
3+ years experience in at least one of the performance testing tools (Prefer JMeter or ReadyAPI-LoadUI)

Job Responsibility

Overall Test Management: Oversee test management, traceability matrix, and provide test status reporting
Test Automation: Design, develop, and execute test automation frameworks and suites
Evaluate and maintain existing manual and automated test cases and procedures
Performance Testing: Conduct load and stress tests using enterprise-level automation tools
Results Analysis: Interpret test results and prepare comprehensive test reports
Collaboration: Participate in project-wide reviews of requirements, system architecture, and detailed design documents
Act as the key point of contact for other test engineers with automation needs
Environment Management: Manage and maintain physical, virtualized, and simulated test environments
Integration and Issue Resolution: Identify and resolve issues arising from integrating application software with other components
Code Coverage and Reviews: Assist in reviewing and determining the code coverage of unit tests

Fulltime

Sr. Quality Engineer

In this critical role, you’ll provide quality oversight and technical leadership...

Location

United States , Buford

Salary:

130000.00 - 149000.00 USD / Year

Beacon Hill

Expiration Date

Until further notice

Requirements

Bachelor’s degree in chemistry, Chemical Engineering, Biomedical Engineering, Radiochemistry, Pharmaceutical Sciences, Biological Sciences, or related field
A Minimum of 5 years of experience in quality engineering, quality assurance, or validation within regulated environments
Experience working with radioisotope production, radiochemistry, pharmaceutical manufacturing, or nuclear materials is REQUIRED
Experience supporting Drug Master File (DMF) submissions or pharmaceutical regulatory filings preferred
Experience supporting process validation, equipment qualification, and GMP documentation
Strong knowledge of cGMP and regulated quality systems (FDA, ISO, pharmaceutical, or medical device)
Working knowledge of radiochemistry, radioisotope production, or nuclear materials handling preferred
Experience with risk management methodologies, deviation investigations, and CAPA systems
Strong technical writing and documentation skills supporting regulated manufacturing environments
Ability to translate development activities into compliant production documentation and regulatory support packages

Job Responsibility

Ensure compliance with 21 CFR Parts 210 and 211 and/or 21 CFR Part 212 where applicable to radioisotope production activities
Support implementation and maintenance of quality systems consistent with pharmaceutical cGMP requirements
Provide quality oversight for radioisotope production, purification, packaging, and distribution processes
Participate in internal audits and regulatory inspections
Develop, review, and approve SOPs, batch production records, validation protocols, qualification documentation, and technical reports
Ensure production and development documentation complies with data integrity and recordkeeping requirements
Support development and maintenance of master batch records and production documentation
Lead or support validation and qualification activities for radioisotope production processes
Develop and execute validation protocols
Support qualification of production equipment, hot-cell systems, and laboratory instrumentation

What we offer

Career growth opportunities
Work on innovative projects with real patient impact
Collaborative, mission-driven culture
Competitive benefits package

Fulltime

Sr. Quality Engineer

We are currently seeking a Sr. Quality Engineer to join our team in Chennai, Tam...

Location

India , Chennai

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

6+ years of experience in test automation: Selenium/Java/Cucumber/REST Assured (both UI and API automation) or Selenium/.NET/Cucumber/REST Sharp
5+ years of experience in software testing and writing automation scripts using Java, C#, and/or JavaScript/TypeScript
5+ years of experience in designing functional and end-to-end test cases to ensure comprehensive test coverage
At least 4+ year of experience using a test automation tool like Selenium/Cucumber/ Java or Selenium/C#.net/Spec Flow/Rest assured or similar frameworks
3+ years of experience in test automation with AMQ,WMQ, Kafka, Couchbase and GCPS
3+ years of experience with OpenShift and Kubernetes
Knowledge in Behavior-Driven Design (BDD) principles and the use of Cucumber (or similar) testing frameworks
3+ years experience in at least one of the performance testing tools (Prefer JMeter or ReadyAPI-LoadUI)

Job Responsibility

Overall Test Management: Oversee test management, traceability matrix, and provide test status reporting
Test Automation: Design, develop, and execute test automation frameworks and suites
Evaluate and maintain existing manual and automated test cases and procedures
Performance Testing: Conduct load and stress tests using enterprise-level automation tools
Results Analysis: Interpret test results and prepare comprehensive test reports
Collaboration: Participate in project-wide reviews of requirements, system architecture, and detailed design documents
Act as the key point of contact for other test engineers with automation needs
Environment Management: Manage and maintain physical, virtualized, and simulated test environments
Integration and Issue Resolution: Identify and resolve issues arising from integrating application software with other components
Code Coverage and Reviews: Assist in reviewing and determining the code coverage of unit tests

Fulltime

Sr. Quality Engineer

We are currently seeking a Sr. Quality Engineer to join our team in Chennai, Tam...

Location

India , Chennai

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

6+ years of experience in test automation: Selenium/Java/Cucumber/REST Assured (both UI and API automation) or Selenium/.NET/Cucumber/REST Sharp
5+ years of experience in software testing and writing automation scripts using Java, C#, and/or JavaScript/TypeScript
5+ years of experience in designing functional and end-to-end test cases to ensure comprehensive test coverage
At least 4+ year of experience using a test automation tool like Selenium/Cucumber/ Java or Selenium/C#.net/Spec Flow/Rest assured or similar frameworks
3+ years of experience in test automation with AMQ,WMQ, Kafka, Couchbase and GCPS
3+ years of experience with OpenShift and Kubernetes
Knowledge in Behavior-Driven Design (BDD) principles and the use of Cucumber (or similar) testing frameworks
3+ years experience in at least one of the performance testing tools (Prefer JMeter or ReadyAPI-LoadUI)

Job Responsibility

Overall Test Management: Oversee test management, traceability matrix, and provide test status reporting
Test Automation: Design, develop, and execute test automation frameworks and suites
Evaluate and maintain existing manual and automated test cases and procedures
Performance Testing: Conduct load and stress tests using enterprise-level automation tools
Results Analysis: Interpret test results and prepare comprehensive test reports
Collaboration: Participate in project-wide reviews of requirements, system architecture, and detailed design documents
Act as the key point of contact for other test engineers with automation needs
Environment Management: Manage and maintain physical, virtualized, and simulated test environments
Integration and Issue Resolution: Identify and resolve issues arising from integrating application software with other components
Code Coverage and Reviews: Assist in reviewing and determining the code coverage of unit tests

Fulltime

Sr. Quality Engineer

Responsible for overseeing our quality management system, ensuring compliance wi...

Location

Mexico , Apodaca

Salary:

Not provided

Hunter Douglas

Expiration Date

Until further notice

Requirements

Knowledge of quality management systems (ISO 9001, etc.)
Experience with quality tools and methodologies (APQP, FMEA, SPC, etc.)
Problem-solving and analytical skills
Effective communication and interpersonal skills
Ability to work collaboratively in a team environment
Computer Soft Skills
Team Work
Excellent Communication
Teamwork
Conflict management

Job Responsibility

Develop and implement quality standards, procedures, and controls
Conduct audits and inspections to ensure adherence to quality requirements
Participate in investigations and root cause analysis for quality issues and implement corrective actions
Collaborate with cross-functional teams to resolve quality-related concerns
Participate into continuous improvement projects to enhance product quality and efficiency
Interface with customers and suppliers on quality matters

What we offer

Competitive compensation package including annual bonus
Generous benefits package including major medical expenses and life insurance
Vacation days
Vacation premium
Paid time off
Food vouchers
Career developmental opportunities
A company culture that prioritizes internal development

Fulltime

Sr. Quality Engineer

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Detail Oriented
Continuous Learner
Courageous
Collaborative
Critical Thinker
Influential

Job Responsibility

To review executed protocols of equipment, utility, process validation, cleaning validation, Utility and facility /HVAC qualification
To coordinate with cross functional departments for execution of all validation activities & escalate to HOD regarding any non-conformity from planning
To review calendars for various periodic qualifications & get it reviewed and approved by HOD
To track QMS documents like Change Control Management, Corrective and Preventive Action, OOS and Non-conformance for the validation activity and review and approve the investigation report
To ensure timely closure of the DCRs, CCM tasks, investigation report due to any NCR/OOS
To ensure timely completion of the self and subordinated assigned trainings
To participate in the Change Control Pre- Assessment meetings and perform the impact assessment of the assigned change controls in Trackwise
To review and approve the scheduled validation activity as per monthly calendar and send it to the cross functional & Planning department in advance for execution planning before the scheduled date
To ensure implementation of validation, qualification activities & inform HOD for any non-conformity deviated from written procedure
To ensure timely/contemporaneous (wherever applicable) data recording and compilation of reports during execution

What we offer

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

Sr Quality Engineer, Validation

This is where you make a difference in our patients’ safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager
To attend training of each protocol before execution of any validation and qualification activity
To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA

Job Responsibility

Prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
Coordinate with cross functional teams of all departments for execution of all validation activities
Prepare monthly and annual calendars for various periodic qualification/validations
Monitor QMS elements related to validation activity and ensure proper closure of QMS documents
Review scheduled validation activity as per calendar
Ensure samples withdrawal during process validation
Ensure compilation of executed protocols and observation sheets
Coordinate with projects for new equipment installation and prepare protocol
Attend training of each protocol before execution
Collect data & compile summary report for submission to International Regulatory Affairs (IRA)

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 Quality Engineer, Validation

This is where you make a difference in our patients' safety. As a member of the ...

Location

India , Ahmedabad

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed
To ensure the CFS closure of respective documents
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager
To attend training of each protocol before execution of any validation and qualification activity

Job Responsibility

To prepare, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed
To ensure the CFS closure of respective documents
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager
To attend training of each protocol before execution of any validation and qualification activity

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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Sr. Quality Engineer

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