Equipment Software Quality Engineer II

Job description

### Key Responsibilities - Provide support to the validation department in regards to decisions on what systems require validation as well as support the validation/remediation of software installed in the company, maintain the change control of the software and provide guidance in IQ creation and execution. - Identify areas that may require software validation and advice system owners about validation requirements. - Analyze areas for improvement and recommend/advice about software solutions. - Maintain procedures related to Software Validation. - Support project transfer teams on Equipment Software Qualification and other non-device software validation activities to ensure compliance requirements are met. - Participate in Equipment Qualification Strategy and Planning meetings. - Support qualification deliverables review and approval activities. - Partner with cross-functional stakeholders to ensure successful software validation and compliance execution. - Support software-related quality processes including change control, risk management, NCEP, and CAPA activities. ### ### Requirements - Minimum Bachelor’s Degree in Engineering discipline or related field of study or related technical field. - ASQ Certified Software Quality Engineering Certification (CSQE) or related professional certifications are valued. - 3-4 years' experience in Quality, QA or related medical device experience. - Working knowledge of Medical Device Quality Management System. - Knowledgeable in Quality System Regulations, Medical Device Regulations, ISO 13485 Quality Standards, FDA 21 CFR Part 820 and FDA 21 CFR Part 11. ### ### Required Skills - Serves as Software QA representative for Software Control Projects, NPI as well as sustaining efforts. - Support other Software Quality related processes such as non-device software related NCEP/CAPA and risk management. - Work with cross-functional teams to resolve quality issues related to software. - Software QA experience within a regulated environment. - Strong attention to detail with the ability to think critically. - Ability to work proactively and independently. - Ability to manage multiple priorities and work efficiently in a fast-paced environment. - Knowledge of software validation lifecycle, change control, and computerized system validation. - Strong documentation, problem-solving, and communication skills. - Experience with Equipment Software Qualification and Validation activities. - Qualification protocol review and approval experience. - Stakeholder management and cross-functional collaboration skills. **About Us** As a global medical technology leader for more than 45 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.