Engineer Software Quality Principle
Posted
This is a non-exempt position. The Sr. Quality Assurance Professional within Client Diagnostics will Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes.
" Responsible for regulatory compliance of healthcare products
" General - Defines project goals and milestones.
" Responsible for timely project completion.
" Provides solutions to a wide range of difficult problems.
" Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
" May lead projects with cross-functional or broader scope.
" Interacts effectively with employees, manager, and cross-functional peers.
" May represent own team while on cross-functional project teams with other functional leaders.
" Communicates confidently and effectively with management, peers, and key stakeholders.
" Implements tactical solutions related to assignment.
" Able to contribute functional skills and expertise broadly.
" Directly influences project direction and scope.
" Scope includes one or more QA functions, with general knowledge of other related disciplines.
" Provides guidance and trains other Professionals and Technicians.
" May provide oversight to one or more QA professionals and/or contractors.
" Quality System Compliance - Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry.
" Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
" Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
" Risk Management - Ensures evaluation of product safety and efficacy and elevation of risk-based issues.
" Creates and reviews risk management documentation to reduce or eliminate risk.
" Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
EDUCATION AND EXPERIENCE:
Required
" Apprenticeship or bachelor s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
" At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
" Preferred experience in the Healthcare industry.
" Has a history of completing successful projects and driving positive compliance outcomes?
Preferred
" Knowledge of Software Development Lifecycle
" Knowledge of Cloud based software applications
" Knowledge of Cybersecurity standards
" Knowledge of Agile Development Methodologies
Top 5 skills/requirements:
" Execution of SDLC activities and defect life cycle; author/review/approval of deliverables.
" End to end manual/automated test execution (functional, regression, UAT, etc.)
" Quality mindset; clear ownership of assigned assignments thru completion.
" Proven ability to step into existing systems/processes quickly
" Previous SQA role employee at Client; experience with use of ALM application.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
" Responsible for regulatory compliance of healthcare products
" General - Defines project goals and milestones.
" Responsible for timely project completion.
" Provides solutions to a wide range of difficult problems.
" Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
" May lead projects with cross-functional or broader scope.
" Interacts effectively with employees, manager, and cross-functional peers.
" May represent own team while on cross-functional project teams with other functional leaders.
" Communicates confidently and effectively with management, peers, and key stakeholders.
" Implements tactical solutions related to assignment.
" Able to contribute functional skills and expertise broadly.
" Directly influences project direction and scope.
" Scope includes one or more QA functions, with general knowledge of other related disciplines.
" Provides guidance and trains other Professionals and Technicians.
" May provide oversight to one or more QA professionals and/or contractors.
" Quality System Compliance - Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry.
" Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
" Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
" Risk Management - Ensures evaluation of product safety and efficacy and elevation of risk-based issues.
" Creates and reviews risk management documentation to reduce or eliminate risk.
" Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
EDUCATION AND EXPERIENCE:
Required
" Apprenticeship or bachelor s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
" At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
" Preferred experience in the Healthcare industry.
" Has a history of completing successful projects and driving positive compliance outcomes?
Preferred
" Knowledge of Software Development Lifecycle
" Knowledge of Cloud based software applications
" Knowledge of Cybersecurity standards
" Knowledge of Agile Development Methodologies
Top 5 skills/requirements:
" Execution of SDLC activities and defect life cycle; author/review/approval of deliverables.
" End to end manual/automated test execution (functional, regression, UAT, etc.)
" Quality mindset; clear ownership of assigned assignments thru completion.
" Proven ability to step into existing systems/processes quickly
" Previous SQA role employee at Client; experience with use of ALM application.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
