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Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your life's work.
Senior Software QA Engineer, Quality Systems
About this role:
This is a senior role within the Marlborough Quality Systems group to ensure that BSC's Software Quality methods, processes and procedures are maintained and implemented for all equipment and processes used at the Marlborough site. The role is also responsible for ensuring that Digital Health applications for the Endoscopy and Urology & Pelvic Health divisions are appropriately assessed and documented to ensure compliance with all relevant standards and regulations.
Provides Software Quality Assurance leadership at the Marlborough site. Develops, modifies, applies and maintains standards for Software Quality methods, processes and procedures which meet Boston Scientific and external regulatory requirements and implements against them. Establishes methods for monitoring the compliance of software system processes, standards and procedures. Provides expertise on software validation requirements to project teams that are implementing software systems and provides independent review to teams. Teaches and coaches less experienced colleagues and manages Equipment and Automated Systems (E&AS) program. Drives a culture of continuous improvement and collaboration within the Quality Systems group.
Your responsibilities include:
Demonstrate mastery of the software and equipment validation processes at BSC (examples include ESQ, E&AS, IQSQ, GSM, Spreadsheet Validation).
Must possess a fundamental understanding of quality philosophies, principles, methods, tools, standards and regulatory requirements.
Provide documented assessments of Digital Health applications within the Endoscopy and Urology & Pelvic Health divisions for PPI, PHI, HIPAA, GDPR, ERES, potential Medical Device Classification or other Quality System impacts.
Must understand systems architecture and be able to implement software development and maintenance processes, quantify the fundamental problems and risks associated with various software development methodologies.
Must have a basic understanding of configuration management processes, including planning, configuration identification, configuration control and change management.
Provide insight and expertise on software quality and equipment validation practices for the Marlborough site.
Supports acquisition and integration activities as required providing guidance and direction on acceptability of software and equipment validation deliverables.
Must have a thorough understanding of verification and validation processes. Must be able to analyze test strategies, develop test plans and execution documents, and review deliverables.
Support external audits as required in either a backroom or front room role as required. Act as the site SME for Software Quality during External Audit.
Report on KPI and metric information as required to support divisional or site needs.
Champions continuous improvement and innovation from a quality perspective within the department.
Supervision and management of other personnel, as required.
Representation of Marlborough site on various Communities of Practice and active engagement in those communities.
What we're looking for in you:
B.S. or M.S. degree in Software Engineering, Computer Science or related technical discipline
3+ years of related work experience in a regulated medical industry is desired
Excellent written and verbal communication skills
Working knowledge and understanding of QSR, ISO and EU MDR and other medical device industry quality requirements
Thorough understanding of FDA's General Principles of Software Validation (GPSV)
Understand aspects of HIPAA and GDPR compliance practices is desired
Understanding of Software Development Life Cycle
Proven ability to work well as part of a team or alone with minimum supervision
Demonstrated ability to identify and work with cross functional organizations to solve problems
Strong command of MS Office Word, Excel, Powerpoint, Visio
Ability to rapidly learn and use new applications
Previous experience in Software Quality
Experience in the medical device industry
Working knowledge of regulations and standards related to medical devices
Previous experience with BSC systems
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 444968