Equipment Software Quality Engineer II

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.

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.

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.