Principal Quality Systems Engineer

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.

This Principal Quality Systems Engineer role is a high-impact position responsible for leading complex, global quality system integration initiatives by designing and executing strategies that align acquired entities with Boston Scientific’s Quality System while maintaining regulatory compliance and business continuity. Drawing on deep quality systems expertise and strong cross‑functional leadership, you will partner across sites, functions and newly acquired organizations to resolve complex integration challenges and drive scalable, enterprise‑wide process improvements.

This hybrid position is located at Valencia Technologies Corporation in Valencia, California. The role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or relocation assistance for this position at this time.

• Lead global Quality System integration programs for acquisitions, including the development and execution of integration strategies, transition plans and governance models that align acquired entities with the Boston Scientific Global Quality Management System while maintaining compliance and business continuity.
• Serve as the primary Quality integration leader and cross‑functional partner, collaborating with R&D, Operations, Regulatory Affairs, Supply Chain and acquired‑site leadership to drive alignment, resolve complex quality system gaps and ensure successful execution of integration milestones.
• Drive end‑to‑end quality system transformation and continuous improvement initiatives, including CAPA, audit readiness, document and records control, and training processes, with accountability for measurable compliance outcomes and operational effectiveness across integrating sites.
• Lead high‑visibility, division wide and enterprise‑wide projects requiring strategic problem‑solving, influence without authority and independent decision‑making in fast‑paced integration environments.
• Assess and mitigate integration risks by identifying compliance gaps, establishing remediation plans and implementing sustainable, scalable solutions aligned with FDA, ISO, MDR and corporate requirements.
• Act as a senior technical subject matter expert and mentor, coaching teams on quality system expectations, integration best practices and structured problem‑solving methodologies while strengthening organizational capability.
• Influence global quality strategy and long‑term quality system evolution by shaping how quality systems are deployed across newly acquired businesses, driving standardization and enabling future growth through repeatable integration models.

• Bachelor’s degree in Engineering or a related technical field.
• Significant experience in a regulated industry, preferably within the medical device industry.
• Demonstrated experience working within Quality Systems, including CAPA, change control, design controls, supplier controls, internal and external audits, and post‑market quality activities.
• Strong working knowledge of global Quality System requirements, regulations and standards.
• Proven track record of leading complex, cross‑functional initiatives and driving results.
• Strong written and verbal communication skills.
• Experience applying quality methodologies and maintaining compliant quality systems.
• Ability to interpret, implement and ensure adherence to procedural and regulatory requirements.
• Strong project leadership skills with ownership of large‑scale initiatives.
• Demonstrated mentorship and technical leadership capabilities.
• Ability to operate independently and effectively in ambiguous, fast‑paced environments.
• Ability to manage multiple priorities while driving execution and accountability.