Onsite Senior Quality Engineer — 18-Month Term

Boston Scientific Gruppe; California (MO); Hybrid; USD 89,000 - 170,000; Full time

Job summary

Boston Scientific is seeking a Senior Quality Engineer for an onsite role in Valencia, CA. This 18-month defined-term position will serve as a quality leader across Manufacturing Quality and Quality Systems, driving compliance with ISO 13485 and QMSR while supporting production operations and audit readiness.

The role requires collaboration with Operations, Regulatory Affairs, R&D and other stakeholders, with responsibilities including leading investigations, reviewing validation data, and

Qualifications

• Bachelor's degree in science, engineering or 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 QMSR.
• Proven ability to resolve complex issues using structured problem-solving methodologies.
• Experience leading nonconforming event risk assessments and quality investigations.

Responsibilities

• Serve as the Quality representative and SME, guiding quality and regulatory compliance.
• Collaborate cross-functionally with Operations, Manufacturing, Supply Chain, Regulatory Affairs, R&D and other stakeholders to resolve quality issues.
• Interpret drawings, procedures and specs to ensure compliance with requirements.
• Lead or support quality investigations including defects, CAPA, and disposition of nonconforming product.
• Review and approve validation, operational and test data for compliance with QMS requirements.
• Support internal and external audits ensuring regulatory and quality system compliance.

Skills

Regulatory knowledge

Quality systems

Problem solving

Data analysis

Investigations

Education

Bachelor's degree

Job description

Boston Scientific is seeking a Senior Quality Engineer for an onsite role in Valencia, CA. This 18-month defined-term position will serve as a quality leader across Manufacturing Quality and Quality Systems, driving compliance with ISO 13485 and QMSR while supporting production operations and audit readiness.

The role requires collaboration with Operations, Regulatory Affairs, R&D and other stakeholders, with responsibilities including leading investigations, reviewing validation data, and