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Boston Scientific

Principal Quality Systems Engineer

Posted 4 Days Ago
Be an Early Applicant
In-Office
Santa Clarita, CA, USA
107K-203K Annually
Expert/Leader
In-Office
Santa Clarita, CA, USA
107K-203K Annually
Expert/Leader
Lead global quality system integration for acquisitions, aligning acquired entities with Boston Scientific QMS. Drive CAPA, audits, document control, training, risk remediation, and cross-functional initiatives to ensure regulatory compliance (FDA, ISO, MDR) and business continuity. Mentor teams, shape enterprise quality strategy, and deliver scalable integration models and measurable compliance outcomes.
The summary above was generated by AI

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 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.


Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.


Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.


Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.


Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.  

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