Job Description

About This Role: Develops, establishes, and maintains software quality assurance methodologies, systems, and practices that meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities. Provides focused software quality assurance support within new product development, operational, or system/services support.
:

• Working within a team of Software Quality Assurance Engineers that support manufacturing, laboratory, R&D, and IT systems.
• Actively contributing to all aspects of Software Quality Assurance activities in an FDA-regulated medical device environment and ensuring that software verification and validation is carried out in compliance with site/corporate policies and procedures.
• Performing independent reviews of design, development, and testing of software/firmware used in Boston Scientific product lines throughout their entire System Development Life Cycle.
• Reviewing and approving documentation associated with qualification planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, test protocols, requirements trace matrix, and qualification reports along with support documentation for equipment qualification.
• Reviewing and approving changes to existing systems from a Software QA perspective, ensuring changes are implemented in compliance with internal procedures and external standards.
• Reviewing test results for GDP compliance and ensuring that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed.
• Ensuring that best software QA practices are employed by all departments so that software/firmware-based systems are developed, qualified, and maintained in a manner that provides assurance the system conforms to both internal and external requirements.
• Supporting site audits, non-conforming events, and CAPAs as required.
• Establish and promote a work environment that supports the Quality Policy and Quality System.
• Establish and cultivate internal business relationships to facilitate task completion and actively participate in project teams.

Job Requirements:

• Bachelor's level degree or higher in Science/Engineering/Software discipline.
• Minimum of 4 years of related work experience in Software QA and/or computer systems validation.
• Knowledge of the System Development Life Cycle (SDLC), preferably with automated manufacturing and computerized lab systems.
• Understanding of 21 CFR Part 11 (electronic records/electronic signature).

Preferred Qualifications:

• Experience in supporting the manufacturing of medical devices or other regulated industry.
• Ability to understand and evaluate procedural documents to ensure compliance with all applicable regulations and requirements.
• Strong organizational skills with the ability to multitask and prioritize competing responsibilities in a fast-paced environment.
• Customer service-oriented with the ability to communicate effectively (written and verbally) with individuals at all levels.
• Ability to work independently and collaborate with internal teams.
• Strong problem-solving and critical thinking skills; analytical, process, and results oriented.
• Working knowledge of PLC and SCADA systems.

Skills Required