Job Title: Supplier Quality Engineer – Medical Devices
Job Summary
We are seeking a detail-oriented
Supplier Quality Engineer (SQE) with experience in the medical device, healthcare products, or pharmaceutical industry to ensure the quality, compliance, and performance of suppliers throughout the supply chain. The ideal candidate will be responsible for supplier qualification, supplier audits, quality improvement initiatives, incoming quality management, and ensuring compliance with regulatory and quality requirements including ISO 13485, FDA 21 CFR Part 820, ISO 14971, and GMP.
Key Responsibilities
Supplier Quality Management
- Lead supplier qualification, approval, and onboarding activities to ensure compliance with company and regulatory requirements.
- Conduct supplier risk assessments and establish supplier quality agreements.
- Monitor supplier performance through key quality metrics, including PPM, SCAR closure, on-time delivery, audit performance, and non-conformance trends.
- Develop and maintain approved supplier lists (ASL).
Supplier Audits & Compliance
- Plan, perform, and lead supplier audits to assess compliance with ISO 13485, GMP, FDA QSR, and company quality requirements.
- Support regulatory inspections and external audits involving supplier-related processes.
- Track audit findings and ensure timely closure of corrective actions.
Supplier Corrective Actions
- Lead Supplier Corrective Action Requests (SCAR) investigations and resolution activities.
- Conduct root cause analysis using quality tools such as 5 Whys, Fishbone Diagram, and Fault Tree Analysis.
- Verify effectiveness of implemented corrective and preventive actions.
Incoming Quality & Non-Conformance Management
- Manage supplier-related non-conformances and material quality issues.
- Review and disposition incoming inspection failures and supplier complaints.
- Implement containment actions and coordinate supplier investigations.
- Drive reduction of supplier defects and improve incoming quality performance.
New Product Introduction (NPI) Support
- Partner with R&D, Manufacturing, Purchasing, and Regulatory Affairs teams to support supplier selection for new products.
- Review supplier process validation documentation and manufacturing capabilities.
- Ensure supplier readiness for new product launches and engineering changes.
Risk Management
- Participate in supplier risk management activities in accordance with ISO 14971.
- Support PFMEA, DFMEA, process risk assessments, and supplier risk mitigation plans.
- Evaluate critical component suppliers and establish appropriate monitoring controls.
Validation & Change Control
- Review supplier validation documentation, including IQ/OQ/PQ and process validation reports.
- Assess supplier change notifications and ensure compliance with change control requirements.
- Support qualification and requalification of supplier manufacturing processes.
Continuous Improvement
- Drive supplier quality improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
- Analyze supplier quality trends and develop improvement plans.
- Collaborate with suppliers to reduce defects, improve process capability, and enhance product quality.
Documentation & Compliance
- Maintain supplier quality records in accordance with QMS requirements.
- Ensure supplier documentation complies with ISO 13485, FDA requirements, GMP, and internal procedures.
- Support document control activities related to supplier quality and compliance.
QMS – Additional Responsibility
- Support and maintain the Quality Management System (QMS) in compliance with ISO 13485 and regulatory requirements.
- Lead and support CAPA (Corrective and Preventive Actions) investigations, root cause analysis, and effectiveness checks.
- Perform Internal Audits, Supplier Audits, and support external regulatory audits (FDA, notified bodies).
- Review and approve design documentation, including DHF (Design History File), DMR (Device Master Record), and DHR (Device History Record).
- Participate in risk management activities (ISO 14971), including hazard analysis, FMEA, and risk control implementation.
- Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs) for new product development and process validation.
- Ensure compliance with Good Manufacturing Practices (GMP) and quality standards.
- Handle non-conformance reports (NCR) and lead investigations for product or process deviations.
- Support validation activities (IQ/OQ/PQ, software validation, process validation).
- Drive supplier quality management, including qualification, monitoring, and performance evaluation.
- Analyze quality data and implement continuous improvement initiatives (Lean, Six Sigma).
Required Qualifications
- Bachelor's Degree in Engineering, Biomedical Engineering, Manufacturing Engineering, Quality Engineering, Life Sciences, or related discipline.
- 3-8 years of experience in Supplier Quality Engineering, Quality Engineering, or Supplier Development within Medical Devices, Healthcare Products, Electronics Manufacturing, or Pharmaceutical industries.
- Strong knowledge of:
- ISO 13485
- FDA 21 CFR Part 820
- ISO 14971
- GMP
- Supplier Quality Management Systems
- Experience conducting supplier audits and managing supplier corrective actions.
- Strong root cause investigation and problem-solving skills.
- Experience with incoming quality control, supplier qualification, and supplier performance monitoring.
- Knowledge of quality tools and methodologies:
- SPC
- CAPA
- 8D
- 5 Why Analysis
- Fishbone Analysis
- FMEA
- Six Sigma
Preferred Qualifications
- ASQ Certified Quality Engineer (CQE).
- Six Sigma Green Belt or Black Belt certification.
- Experience with Class II/III Medical Devices.
- Experience with sterile products and regulated manufacturing environments.
- Knowledge of supplier validation and process qualification requirements.
- Experience with electronic QMS systems (eQMS).
- Experience in:
- Supplier Development
- Contract Manufacturing Organizations (CMO)
- SMT (PCBA Manufacturing)
- High Level Assembly (HLA) Manufacturing
- Mechanical Components and Electromechanical Assemblies
- Familiarity with regulatory submissions such as CE Marking and FDA 510(k).
Key Competencies
- Supplier Quality Management
- Supplier Development and Relationship Management
- Audit and Compliance Expertise
- Risk Assessment and Mitigation
- Strong Analytical and Problem-Solving Skills
- Effective Communication and Negotiation Skills
- Cross-Functional Collaboration
- Continuous Improvement Mindset
- Attention to Detail and Regulatory Compliance Focus
Work Environment
- Office and manufacturing floor interaction.
- Domestic and international travel for supplier audits, supplier development activities, and qualification visits.
- Participation in regulatory inspections and quality system audits.
Example KPIs
- Supplier PPM (Parts Per Million Defects)
- Supplier Audit Compliance Score
- SCAR Closure Cycle Time
- Incoming Quality Acceptance Rate
- Supplier On-Time Corrective Action Closure
- Supplier Quality Improvement Metrics
- Cost of Poor Supplier Quality (COPQ)
- Reduction in Supplier-Related Non-Conformances
- Supplier Risk Reduction Effectiveness
- Approved Supplier Performance Rating
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