Purpose Statement

The Senior Software Quality Assurance role is required to ensure that compliance to the site, corporate and regulatory body equipment & automated system and software validation requirements.

Key Responsibilities

• Subject Matter Expert on equipment & automated systems validation.
• Strong working knowledge on Software Validation
• Responsible for the review and approval of all documentation through the equipment and automated systems lifecycle.
• Ensure regulatory compliance with internal and external validation regulations, particularly with BSC corporate non-device software requirements.
• Ensure relevant procedures are kept up to date and maintained to the relevant BSC standards and to industry best practice.
• Provide guidance and assistance with the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all applications supporting the quality system and equipment and automated systems.
• Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
• Provides guidance, training and direction the non device software lifecycles to staff across various functions.
• Provide software validation/compliance/part 11 leadership.
• Take part in vendor audits of critical equipment vendors.
• Present relevant documentation during internal and external audits.

Qualifications

• Bachelors’ degree in relevant STEM discipline with 5+ years experience in ideally a medical device or highly regulated manufacturing environment
• Demonstrated experience planning and executing testing of complex applications
• Demonstrated success working in a highly collaborative, matrix environment, with a track record of accomplishments with measurable business impact
• Strong sense of personal accountability and courage to change how we work
• Proven aptitude to learn quickly and improve processes
• Strong verbal and written communication skills and the ability to collaborate effectively with team members and business partners
• Ability to negotiate, influence, and collaborate to build successful relationships