• 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 • Experience with use of ALM application.