Senior Quality Engineer – Onsite Quality Leader

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

Job summary

Boston Scientific Valencia Technologies is seeking a Senior Quality Engineer to act as the quality representative for manufacturing operations and Quality Systems. You will drive regulatory compliance, lead investigations, and support audits across the site, ensuring products meet quality and safety standards.

The role requires collaboration with Manufacturing, Regulatory Affairs, R&D, and Operations to resolve complex quality issues and improve process effectiveness.

Qualifications

• Bachelor's degree in science, engineering or related technical discipline.
• Minimum 5 years in the medical device or pharmaceutical industry.
• Strong knowledge of ISO 13485 and QMSR.
• Experience leading nonconforming event risk assessments and quality investigations.
• Audit experience preferred.

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

Bachelor's degree

5+ years experience

ISO 13485

QMSR

Problem solving

Quality investigations

Data analysis

Education

Bachelor's degree in science/engineering

Job description

Boston Scientific Valencia Technologies is seeking a Senior Quality Engineer to act as the quality representative for manufacturing operations and Quality Systems. You will drive regulatory compliance, lead investigations, and support audits across the site, ensuring products meet quality and safety standards.

The role requires collaboration with Manufacturing, Regulatory Affairs, R&D, and Operations to resolve complex quality issues and improve process effectiveness.