Engineer, Software Quality Principle

Description:
This is a non-exempt position. The Sr. Quality Assurance Professional within 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 bachelors 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; experience with use of ALM application.