Supplier Quality Engineer

Key Responsibilities

• Supplier Qualification and Management
• Evaluate, qualify, and approve new suppliers based on quality, technical, and regulatory requirements.
• Conduct supplier risk assessments and maintain the Approved Supplier List (ASL).
• Monitor supplier performance through quality metrics, delivery performance, defect rates, and scorecards.
• Manage supplier re‑evaluation and periodic performance reviews.
• Supplier Audits and Compliance
• Plan and conduct supplier audits, including initial qualification, surveillance, and for‑cause audits.
• Ensure supplier compliance with ISO 13485, applicable FDA Quality Management System Regulation (QMSR), and other relevant regulatory requirements.
• Review supplier quality systems, manufacturing processes, inspection methods, and documentation.
• Track audit findings and verify the effectiveness of corrective actions.
• Non‑Conformance and CAPA Management
• Investigate supplier‑related non‑conformances, material rejections, and quality complaints.
• Coordinate root cause analysis using methods such as 5 Whys, Fishbone Analysis, and 8D.
• Drive supplier corrective and preventive actions (SCAR/CAPA) and ensure timely closure.
• Assess the effectiveness of corrective actions and prevent recurrence of quality issues.
• Quality Planning and Engineering
• Review supplier PPAP/FAI documentation, where applicable, inspection plans, and control plans.
• Support risk management activities, including PFMEA and supplier process risk assessments.
• Participate in APQP, process validation, and supplier change‑control activities as applicable.
• Support qualification of new components, materials, manufacturing processes, and suppliers.
• Documentation and Continuous Improvement
• Maintain supplier audit reports, quality agreements, risk assessments, and qualification records.
• Support incoming inspection improvement and supplier defect reduction initiatives.
• Collaborate with Procurement, Manufacturing, R&D, Regulatory Affairs, and Quality Assurance teams.
• Support internal audits, external audits, and regulatory inspections.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, Industrial Engineering, or a related technical discipline.
• 3–7 years of experience in supplier quality, quality assurance, or quality engineering.
• Relevant experience in the medical device, medical equipment, diagnostics, or regulated healthcare manufacturing industry.
• 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.
• Familiarity with risk management principles, traceability, change control, and document control.
• Strong analytical, problem‑solving, communication, and supplier management skills.

Preferred Qualifications

• Lead auditor or internal auditor training for ISO 13485.
• Knowledge of FDA 21 CFR Part 820 and the Quality Management System Regulation (QMSR).
• Experience with ISO 14971 risk management.
• Familiarity with MDSAP, where applicable.
• Experience with machined components, molded plastics, electronics, sterilization, packaging, or contract manufacturing suppliers.
• Knowledge of statistical process control (SPC), measurement system analysis (MSA), and process capability studies.
• Experience with ERP, QMS, or supplier management systems.

Key Performance Indicators (KPIs)

• Supplier defect and incoming rejection rates.
• Supplier corrective action closure time and effectiveness.
• Supplier audit completion and compliance rates.
• Supplier quality scorecard performance.
• Reduction in supplier‑related non‑conformances.
• Supplier qualification and requalification completion.
• Supplier‑driven cost of poor quality.

Key Skills

Supplier Audits | ISO 13485 | FDA QMSR | Supplier Qualification | SCAR/CAPA | Root Cause Analysis | 8D | PFMEA | Risk Management | FAI | PPAP | Change Control | Non‑Conformance Management | Continuous Improvement.

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”