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Engineer, Software Quality - Principle
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Mindlance
Lake Forest, IL (In Person)
Full-Time
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Job Description
Engineer, Software Quality - Principle#26-12552
Lake Forest, IL
Onsite Job Description
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.