Review supplier quality data, identify trends, and communicate potential risks to management.
Support supplier qualification, onboarding, and requalification activities.
Ensure suppliers meet applicable quality, regulatory, and contractual requirements.
Supplier Audits and Assessments
Plan, conduct, and support supplier audits, including qualification, surveillance, and for-cause audits.
Assess supplier quality systems, manufacturing processes, and compliance with applicable standards and regulations.
Document audit findings and track corrective actions through closure.
Evaluate supplier responses to audit observations and verify effectiveness of implemented actions.
Supplier Nonconformance Management
Lead investigations related to supplier quality issues, including nonconforming materials, components, and services.
Coordinate containment activities and ensure timely resolution of supplier-related quality events.
Facilitate root cause analysis using quality methodologies such as 5-Why, Fishbone Analysis, and Failure Mode and Effects Analysis (FMEA).
Review and approve supplier corrective action reports and monitor implementation progress.
Verify effectiveness of supplier corrective and preventive actions (SCARs).
Cross-Functional Collaboration
Partner with Procurement and Supply Chain teams to support supplier selection and supplier development initiatives.
Collaborate with Manufacturing, Engineering, and Quality teams to address supplier-related production issues.
Participate in product transfers, process changes, and new product introduction activities involving suppliers.
Provide quality input during supplier change notifications and risk assessments.
Risk Management and Continuous Improvement
Identify and assess supplier-related risks that may impact product quality, delivery, or compliance.
Support supplier development activities aimed at improving quality performance and reducing defects.
Participate in continuous improvement initiatives to strengthen supplier quality systems and supply chain robustness.
Utilize statistical analysis and quality tools to drive data-based decision-making.
Compliance and Quality Systems
Ensure supplier quality activities comply with applicable regulations, industry standards, and company quality system requirements.
Maintain supplier quality records, audit reports, and approved supplier documentation.
Support internal audits, customer audits, and regulatory inspections involving supplier controls.
Assist in the development and revision of supplier quality procedures, standards, and work instructions.
Participate in sourcing parts and components and processes associated
Qualifications
Bachelor’ Degree in Engineering, Manufacturing Enginering, or related technical discipline
2 to 5 years of experience in Supplier Quality, Quality Engineering, Manufacturing Quality or related function
Experience in regulated industry such as Medical device or other related field, preferred
Knowledge of Quality Management Systems, including ISO 13485, ISO 9001, FDA Quality System Regulations, or equivalent standards.
Experience conducting supplier audits and supplier assessments.
Understanding of supplier qualification, supplier monitoring, and supplier development processes.
Strong knowledge of CAPA, nonconformance management, root cause analysis, and risk management methodologies.
Familiarity with statistical analysis and quality tools.
Ability to interpret technical drawings, specifications, and manufacturing documentation.
Strong written and verbal communication skills.
Excellent problem-solving and project management abilities.
Willingness to travel to supplier sites as required.
Travel: 10%
Compensation Range: $100,000–$130,000
