Assume a Subject Matter Expert (SME) on Product Software development process activities and related workflows in relation to regulatory compliance, provide ‘solution-based’ problem resolution
Act as Quality specialist in relation to software design and development ensuring conformance and up-to-date information on applicable regulatory requirements including as appropriate ISO 62304, ISO 62366, ISO 14971 and ISO 13485.
Provide interpretation and guidance on industry best practice Software Development Life Cycle (SDLC) methodologies - mentor/train personnel involved in software development in respective to “Best Practices”.
Evaluate the acceptability of products for release, ensuring customer requirements /specifications and internalWaters policies and procedures are met.
Provide leadership and directionon all quality activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, usability, risk management, compliance and product performance.
Actively participate in and/or facilitate the development, review and approval of requirements and deliverablesrequiredtosupport product software development (planning, requirements, architecture, verification/validation etc.) including software risk management, maintenance, configuration management and problem resolution.
Minimum of Bachelors Degree. Preferably within Computer Science, systems engineering or related Engineering fields of study
Minimum 7 years experience supporting quality assurance activities within software development. Preferablywithin regulated industries
Desired - Extensive experience in new product development focused on software / quality engineering related activities in a regulated environment.
Desired - Experience of leading quality assurance activities supporting software development in a regulated environment - ISO 13485, ISO 14971, ISO 62304, ISO 62366 and applicable good manufacturing practice regulations including, 21 CFR part 820.
Strong working knowledge of various Software Development Life Cycle (SDLC) models within a complex hardware-software development environment.
Extensive knowledge of and use a variety of software risk management tools, design and process control activities, usability and validation testing methodologies to drive software product quality for new product development in a ISO 9001 environment.
Demonstrated ability to apply system quality management practices in efficient and effective ways while ensuring compliance. Solutions-based approach to quality, wants to provide “added value”.
Strong leadership, coaching and mentoring skills.
Exceptional interpersonal and communication skills.
Excellent attention to detail. Ability toworkon one’s own initiative. Demonstrate sound judgment/rationale. Excellent report writing and reviewing skills.