Summary:We are seeking an experienced Supplier Quality Engineer (SQE) to support supplier quality initiatives within the Medical Device industry. The ideal candidate will be responsible for ensuring suppliers consistently deliver high-quality materials, components, and services that comply with regulatory requirements and organizational quality standards. This role requires strong expertise in supplier quality management, process validation, risk assessment, PPAP, and quality systems.
Roles & Responsibilities:- Manage supplier quality activities to ensure compliance with company quality standards and regulatory requirements.
- Evaluate, qualify, and onboard new suppliers into the Approved Supplier List (ASL).
- Perform supplier assessments and quality evaluations for new products, components, and process changes.
- Conduct product and feature-level quality impact assessments and maintain supporting documentation.
- Review and approve Production Part Approval Process (PPAP) documentation, including:
Process Flow Diagrams
Control Plans
Process Drawings
Capability Studies
Design Failure Mode and Effects Analysis (DFMEA)
Process Failure Mode and Effects Analysis (PFMEA)
Support supplier process qualification and validation activities, including:
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Measurement System Analysis (MSA)
Test Method Validation (TMV) - Conduct supplier risk assessments, segmentation, and maintain supplier risk profiles.
- Establish and maintain Supplier Quality Agreements with external suppliers.
- Plan, coordinate, and perform supplier audits to ensure ongoing compliance.
- Support supplier selection and qualification activities for new products and engineering changes.
- Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) and Supplier Owned Quality (SOQ) initiatives.
- Route quality documentation through Product Lifecycle Management (PLM) systems and ensure timely approvals and document releases.
- Investigate supplier quality issues, identify root causes, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives.
- Monitor supplier performance through quality metrics, scorecards, and key performance indicators (KPIs).
- Partner with Engineering, Manufacturing, Regulatory, Operations, and Supply Chain teams to resolve supplier quality concerns.
- Support internal and external audits while ensuring compliance with applicable quality management systems.
Qualifications:- Bachelor's degree in Engineering, Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical/scientific discipline.
- Minimum 8+ years of Supplier Quality Engineering experience within the Medical Device industry.
- Strong understanding of FDA regulations, ISO 13485, and medical device quality systems.
- Hands-on experience with supplier qualification, supplier development, and supplier quality management.
- Experience reviewing and approving PPAP documentation.
