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Supplier Quality Group

Your Trusted Partner

Reduce Risks, Ensure Quality

Supplier Quality Group helps medical device, biotech and pharmaceutical manufacturers reduce supply chain and compliance risks and ensure consistent product quality through our comprehensive supplier auditing, monitoring and improvement programs.

Elevate your Supply Chain Quality

Our proven strategies and expertise can elevate your supply chain performance, ensuring compliance and quality at every step of the process.

Leadership in Global Supply Chain Quality

quality for medical device, pharma and biotech
trusted partnership with OEM's and suppliers

Our Services

Supplier Audits and Compliance, Implementing Quality Management Systems, Supplier Training, Supplier  Development, Software and Process Validation, Part Qualification, Supplier Transfers, IOPQ, Data Analytics, BOM and ASL Management

quality process improvement

Processes

Design Transfer, SCAR/CAPA, Part Qualification, Sterilization, Supplier Transfers (insourcing & outsourcing), Manufacturing Quality- Plastics, Metals, Advanced Manufacturing, Post-market Surveillance & Support, IVD/RUO/IUO

collaboration with purchasing, engineering, quality

Training

Quality Systems, Procedures, Supplier Development, Compliance (FDA/cGMP, ISO 13485:2016), Master Data Management, Statistical Methods

manufacturing technology and data management

Technology

E-BOM & S-BOM Management, e-Procurement, Computer Systems Assurance, Digitization, Data Integrity, Data Management, ASL Management, Supplier Change Management, Simulation, Digital Twin & Digital Thread

Our Solutions Portfolio

1

RESOURCES

  • Staffing Operations, Warehousing & Logistics Supplier Quality

  • Supplier Quality expertise in Advanced Manufacturing Technologies & Automation

  • Commodity-specific quality expertise (PCBA, Plastics, Metals, other)

  • Supplier Audits and Audit Response

  • Supplier Development

2

BUSINESS PROCESSES

  • Supplier Training

  • Quality Management System (cGMP, ISO)

  • CAPA/SCAR & Troubleshooting

  • Manufacturing and Process Validation

  • Managing supplier escalations

  • Inspection Readiness (OEM, NB, Agency)

  • Incoming product acceptance, Batch Records, Product Release

  • Supplier Risk Management

3

TECHNOLOGY

  • Supplier Transfers (e.g, to/from  India, China, Mexico) and Localization of BOM

  • Approved Supplier List & Master Data Management

  • Data Analytics, Cost of Poor Quality (COPQ) improvement, and Supplier Monitoring

  • Software Supplier Quality

  • Advanced Manufacturing Technologies

  • Sub-tier supplier management

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