Senior Quality Engineer - 18 Month Defined Term

Boston Scientific; Santa Clarita (CA); On-site; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific in Valencia, CA is seeking a Senior Quality Engineer for the Valencia Technologies site. The role provides quality leadership across Manufacturing Quality and Quality Systems, ensuring compliance with internal procedures and regulatory requirements.

It requires collaboration with Operations, R&D, and others to drive product quality and audit readiness in a defined 18-month term. The role focuses on investigations, nonconforming material disposition, validation review, and

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 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.

Responsibilities

• 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.

Skills

Regulatory knowledge

Quality systems

Problem solving

Data analysis

Risk assessment

Quality investigations

Audit experience

Cross-functional collaboration

Communication (verbal/written)

Team leadership

Education

Bachelor's degree in science or engineering

Job description

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. This is a 18 month defined term position.

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.

Requisition ID:634444

Minimum Salary:$89200

Maximum Salary: $169500

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 byprovidinga 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,neurologicaland 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 specificprohibited substancetest 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.