Senior Quality Engineer

Senior Quality Engineer

Work mode: Onsite Onsite Location(s): Valencia, CA, US, 91355 Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.

About the role: Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. This role is for a Senior Quality Engineer supporting Boston Scientific's Valencia Technologies acquisition. In this role, you will serve as a key Quality representative with responsibility spanning Manufacturing Quality and Quality Systems. You will provide quality leadership and support for production operations while driving compliance across the site's Quality Management System. You will ensure alignment with internal procedures, regulatory requirements and industry standards while supporting product quality, issue resolution, process effectiveness and audit readiness.

Work model, sponsorship, relocation: At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to be on site at Valencia Technologies in Valencia, California, five days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Your responsibilities will include:

• Serve as the Quality representative and subject matter expert, providing guidance, training and support to ensure the consistent application of quality and regulatory requirements.
• Collaborate cross-functionally with Operations, Manufacturing, Supply Chain, Regulatory Affairs, Research and Development (R&D), and other key stakeholders to resolve quality issues.
• Interpret technical drawings, procedures and specifications to ensure compliance with applicable requirements.
• Lead or support quality investigations, including manufacturing defects, failure analyses, corrective and preventive actions, and the disposition of nonconforming product.
• Review and approve validation, operational and test data to ensure compliance with product, process and quality system requirements.
• Support internal and external audits, ensuring compliance with regulatory and quality system requirements.

Qualifications: Required qualifications: Bachelor's degree in science, engineering or a related technical discipline. Minimum of 5 years' experience in the medical device or pharmaceutical industry. Strong understanding of regulatory and quality system requirements, including ISO 13485 and the Quality Management System Regulation (QMSR). Proven ability to resolve complex issues using structured problem-solving methodologies, supported by strong knowledge of quality operations, product risk assessment and data analysis. Experience leading nonconforming event risk assessments and quality investigations. Preferred qualifications: Audit experience. Excellent verbal and written communication skills. Ability to collaborate and communicate effectively across all levels of the organization. Demonstrated ability to work independently and effectively in a team environment. Continuous improvement mindset with a passion for quality.