Senior Supplier Quality Engineer – Audits & Risk

Internetwork Expert; Carlsbad (CA); On-site; USD 110,000 - 125,000; Full time

Job summary

Alphatec Spine, Inc. seeks a Supplier Quality Engineer III to lead supplier quality activities for external product and service suppliers used in spinal implants, instruments, software, and capital equipment.

The role partners across Supply Chain, Purchasing, Operations, R&D, Manufacturing Engineering, Regulatory Affairs, and Quality to ensure supplier performance supports regulatory compliance, product quality, and supply continuity. Strong leadership and audit skills are essential.

Qualifications

• Medical device industry experience required.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, MDSAP, ISO 14971, and purchasing controls.
• Lead Auditor certification or demonstrated ability to independently lead supplier audits.
• Experience leading supplier audits, supplier assessments, SCARs, supplier NCRs, and supplier quality investigations.

Responsibilities

• Lead supplier quality activities including performance management, issue resolution, development, and continuous improvement initiatives.
• Develop strategic relationships with suppliers and serve as the primary quality contact.
• Lead supplier qualification, requalification, classification, and development activities.
• Lead audits, audit reports, finding responses, and effectiveness reviews." ,
• Represent Supplier Quality during internal/external audits and regulatory inspections.

Education

Bachelor's degree in Engineering or related technical discipline

Job description

Alphatec Spine, Inc. seeks a Supplier Quality Engineer III to lead supplier quality activities for external product and service suppliers used in spinal implants, instruments, software, and capital equipment.

The role partners across Supply Chain, Purchasing, Operations, R&D, Manufacturing Engineering, Regulatory Affairs, and Quality to ensure supplier performance supports regulatory compliance, product quality, and supply continuity. Strong leadership and audit skills are essential.