Additional Location(s): N/A

About the role:

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.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This 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 take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

**Note that this hybrid position is located at Valencia Technologies Corporation in Valencia, California.

Your responsibilities will include:
• 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, divisionwide 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.

Qualifications:

Required qualifications:
• 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.

Preferred qualifications:
• Experience with implantable neurostimulation devices.
• Proven ability to influence stakeholders and drive outcomes without direct authority.

Requisition ID: 630228

Minimum Salary: $ 106800

Maximum Salary: $ 202900

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.