Sr. S/W Quality Engineer

Boston Scientific•Arden Hills, MN

19h•$85,000 - $161,500

About The Position

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. Role includes IT/clinical/manufacturing/Quality software and computerized system validation and maintenance. Role requires expertise in software validation as it applies to both Waterfall and an Agile environment.

Requirements

Bachelor’s level degree in Science/Engineering/Software discipline
6 years of related experience, including 3+ years’ experience in Software Quality and validation
Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices
Must have good understanding of quality system requirements and how each quality system element connects
Some experience in working with ‘Agile’ software development and validation methodologies
Some experience/knowledge of work management and testing tools (such as JIRA, Xray, 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

Nice To Haves

People leadership experience a preference

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.
Acts as a subject matter expert on software validation to guide/ coach/ train project teams on effective and efficient implementation of BSC software validation processes.
Demonstrate mastery of the software validation processes at BSC.
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
Communicates the value of the Software Quality process at Boston Scientific and champions departmental or cross-functional software validation initiatives. Ensures buy-in from project team members to the disciplines, decisions and practices of the Software Validation.
Provides structured Quality Assurance activities and metrics to promote efficient and cost-effective operations.