Job Descriptions

Purpose

Develops, modifies, applies and maintains standards for Software Quality methods, processes and procedures which meet Boston Scientific and external regulatory requirements. Provides expertise and conducts evaluation of software systems validation activities including requirements, design, development, integration, test, verification and implementation. Establishes methods for monitoring the compliance of software system processes, standards and procedures. Coaches less experienced colleagues and executes on projects along with other members of the team. The role includes IT/clinical/manufacturing/Quality software and computerized system validation and maintenance. The role requires expertise in software validation as it applies to an Agile environment as well as knowledge of enterprise systems (examples include SAP) validation and spreadsheet validation.

Responsibilities

• Acts as an effective team member providing independent review and guidance on deliverables used to develop, implement and maintain IT/clinical/manufacturing/quality software.
• Demonstrate mastery of the software validation processes.
• Must possess a fundamental understanding of quality philosophies, principles, methods, tools, standards and regulatory requirements.
• Works with the management to understand priorities and plans/provides input to resource and time allocation accordingly.
• Plays key role in providing full guidance and direction on acceptability of Software Quality and Validation deliverables. Demonstrate the ability to lead, acknowledge, develop, communicate & implement a validation strategy to ensure compliance.
• Guides implementation of enterprise systems solutions through planning, system integration, and verification and validation activities.
• Proactive involvement in continuous improvement activities while ensuring that Boston Scientifics’ software systems are defensible for regulatory requirements.
• Contributes to the development, review and / or approval of SOPs and supporting Work Instructions.
• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of Software verification and validation activities

Qualifications & Requirements

• Bachelor’s level degree in Science/Engineering/Software discipline
• 6 years of related experience, including 3+ years’ experience in Software Quality Assurance and validation
• Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11, SoX and cGxP for Medical Devices
• Must have good understanding of quality system requirements and how each quality system element connects
• Experience in working with ‘Agile’ software development and validation methodologies
• Experience in supporting enterprise systems (examples include SAP) validation
• Some Experience/knowledge of work management and testing tools (such as JIRA, qTest)
• Experience working with a diverse population of internal and external customers
• Comfortable speaking and presenting to leadership
• Strong written and verbal communication skills
• Creative and innovative thinking skills
• Experience managing projects and project deliverables to completion
• Comfortable working independently and as part of a cross-functional team
• Ability to manage multiple priorities and work without ambiguity

Skills

• Project management
• Excellent written and verbal communication skills

Experience

• 3+ years