Supplier Quality & Development Engineer

Lever, Inc.; Santa Cruz (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Lever, Inc. is seeking a Supplier Development Engineer to drive supplier qualification, PPAP, and continuous improvement for medical device manufacturing. You will partner with internal teams to improve quality, delivery, and cost while ensuring regulatory compliance.

Responsibilities include audits, CAPAs, risk mitigation, and collaboration across Engineering, Operations, Procurement, and Quality to optimize supplier performance.

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 5+ years of experience in supplier quality engineering or related field.
• Experience with PPAP, APQP, PFMEA, Control Plans, and MSA.
• Experience conducting supplier audits and managing supplier corrective actions.
• Experience with ISO 13485 quality systems and medical device manufacturing.
• Understanding of machining, molding, assembly, electronics, metals, plastics, or medical devices.

Responsibilities

• Lead supplier selection, qualification, onboarding, and performance management.
• Conduct supplier audits and assessments of capabilities and quality systems.
• Develop supplier improvement plans and track metrics.
• Create supplier scorecards for quality, delivery, and cost.
• Support risk assessments and mitigation activities for suppliers.
• Lead PPAP submissions and review key documentation (PFMEA, Control Plans, MSA, CP/Cpk, FAIR).
• Ensure process validations and controls are implemented by suppliers.
• Collaborate with suppliers to resolve PPAP deficiencies and qualification issues.
• Ensure ISO 13485 compliance and regulatory alignment for supplier quality.
• Participate in internal/external audits as supplier quality SME.
• Support change control activities including supplier process changes.

Skills

PPAP

APQP

PFMEA

SPC

MSA

Control Plans

GD&T

Root Cause Analysis

CAPA Systems

Statistical Analysis

Education

Bachelor's degree in Engineering, Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Quality Engineering, or related technical discipline

Tools

ERP

PLM

Quality Management Systems

Job description

Lever, Inc. is seeking a Supplier Development Engineer to drive supplier qualification, PPAP, and continuous improvement for medical device manufacturing. You will partner with internal teams to improve quality, delivery, and cost while ensuring regulatory compliance.

Responsibilities include audits, CAPAs, risk mitigation, and collaboration across Engineering, Operations, Procurement, and Quality to optimize supplier performance.