Quality Engineer: Supplier Quality & Regulatory Compliance

Spectrum Killian; Santa Ana (CA); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401K

Job summary

Spectrum Killian Dental Lab Alliance in California seeks a Quality Engineer to ensure products meet performance, regulatory, and customer expectations across suppliers and internal processes.

You will own the SQMS, conduct supplier audits, drive RCCA and CAPA, and partner with Procurement, Operations, and R&D to deliver reliable, high-quality dental restorations. The role requires hands-on experience in GMP environments, FDA/ISO compliance, and data-driven problem solving.

Qualifications

• Hands-on experience maintaining QMS in FDA/ISO-regulated environments.
• Experience with supplier audits, CAPA, 8D, and RCCA methodologies.
• Proven ability to drive supplier quality improvements and data-driven decisions.

Responsibilities

• Develop and maintain SQMS across contract manufacturers and vendors.
• Conduct supplier qualification audits and first article inspections.
• Establish monthly supplier scorecards for quality and delivery.
• Lead RCCA investigations and verify long-term effectiveness.
• Collaborate with Procurement, Operations, and R&D to drive improvements.
• Lead audits and support FDA inspections.

Skills

Analytical thinking

Process improvement

Quality systems

Supplier management

Effective communication

Cross-functional collaboration

Education

Bachelor’s degree in Engineering, Quality, or related

CSQP certification

CQE certification

Job description

Spectrum Killian Dental Lab Alliance in California seeks a Quality Engineer to ensure products meet performance, regulatory, and customer expectations across suppliers and internal processes.

You will own the SQMS, conduct supplier audits, drive RCCA and CAPA, and partner with Procurement, Operations, and R&D to deliver reliable, high-quality dental restorations. The role requires hands-on experience in GMP environments, FDA/ISO compliance, and data-driven problem solving.