Senior Quality Engineer
Intracept by Boston Scientific
Senior Quality Engineer
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.
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.
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) 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.
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).
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.
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.
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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