Senior Supplier Quality Engineer, Regulated Medical Devices

SKDLA; Santa Ana (CA); On-site; USD 58,000 - 75,000; Full time

Job summary

Spectrum Killian seeks a Quality Engineer to join the Operational Excellence & Quality organization. You will ensure external partners and internal processes deliver products meeting performance, regulatory, and customer expectations, with hands-on experience in regulated systems, supplier audits, and root-cause analysis.

You will drive supplier quality management, RCCA investigations, and continuous improvement, collaborating with Procurement, R&D, and Operations to strengthen process

Qualifications

• Bachelor’s degree in Engineering or related field.
• Experience with FDA/ISO-regulated QMS and supplier audits.
• CSQP or CQE certification is a plus.
• Strong data-driven problem solving and analytical skills.

Responsibilities

• Develop, deploy, and maintain the SQMS across contract manufacturers and design partners.
• Lead supplier RCCA investigations and verify long-term effectiveness through data-driven monitoring.
• Manage monthly supplier scorecards tracking quality, delivery, and corrective action performance.
• Investigate customer complaints and translate insights into design/process improvements.
• Support FDA inspections and third-party audits and ensure regulatory readiness.
• Collaborate with Procurement and Operations to strengthen supplier capabilities.

Skills

Analytical skills

Supplier relationships

Data interpretation

Communication

Audit proficiency

Quality systems

Education

Bachelors in Engineering

CSQP or CQE

Tools

QMS in FDA environments

Job description

Spectrum Killian seeks a Quality Engineer to join the Operational Excellence & Quality organization. You will ensure external partners and internal processes deliver products meeting performance, regulatory, and customer expectations, with hands-on experience in regulated systems, supplier audits, and root-cause analysis.

You will drive supplier quality management, RCCA investigations, and continuous improvement, collaborating with Procurement, R&D, and Operations to strengthen process