Supplier Quality Engineer

Job Summary

We are seeking an experienced Supplier Quality Engineer to manage supplier quality activities for medical device components, raw materials, and outsourced processes. The candidate will be responsible for supplier qualification, audits, quality issue resolution, corrective and preventive actions (CAPA), and ensuring compliance with applicable medical device quality standards and regulatory requirements.

The ideal candidate should have experience working with medical device manufacturers, contract manufacturers, component suppliers, and critical material vendors.

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.”

If you are inclined, I would be happy to set up some time to chat more about your background and career interests to see if there could be a possible match. Please feel free to call me on 732-806-7467 or send me email on nirajk@mindlance.com

Regards

Niraj kumar