Additional Location(s): N/A
About the role:
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.
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: 630303
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.
