Lead Supplier Quality Engineer

Mindlance; El Paso (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Mindlance is seeking a Supplier Quality Engineer to lead supplier qualification, audits, and CAPA activities for regulated medical-device suppliers. You will ensure ISO 13485 and FDA QMSR alignment while collaborating with Procurement, Manufacturing, R&D, and Regulatory Affairs.

The role emphasizes risk management, change control, and continuous improvement of supplier processes, aiming to reduce non-conformances and improve quality metrics.

Qualifications

• Bachelor's degree in engineering or related technical discipline, with relevant regulatory exposure.
• 3–7 years of experience in supplier quality, quality assurance, or quality engineering.
• Working knowledge of ISO 13485 and medical device quality management systems.
• Experience in supplier audits, supplier qualification, SCAR/CAPA, root cause analysis, and non-conformance management.

Responsibilities

• Qualify and manage suppliers based on quality, technical, and regulatory requirements.
• Plan and conduct supplier audits, including initial qualification and surveillance.
• Monitor supplier performance using quality metrics, delivery, defect rates, and scorecards.
• Coordinate supplier re‑evaluation and periodic performance reviews.
• Drive CAPA/SCAR activities and ensure timely closure of actions.
• Collaborate with Procurement, Manufacturing, R&D, Regulatory Affairs, and QA.

Skills

Supplier Audits

ISO 13485

QMSR

SCAR/CAPA

Root Cause Analysis

8D

PFMEA

Risk Management

Change Control

Non-Conformance Management

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Industrial Engineering, or related technical discipline

Tools

ERP systems

QMS software

Job description

Mindlance is seeking a Supplier Quality Engineer to lead supplier qualification, audits, and CAPA activities for regulated medical-device suppliers. You will ensure ISO 13485 and FDA QMSR alignment while collaborating with Procurement, Manufacturing, R&D, and Regulatory Affairs.

The role emphasizes risk management, change control, and continuous improvement of supplier processes, aiming to reduce non-conformances and improve quality metrics.