Supplier Development Engineer

Supplier Quality Management

Lead supplier selection, qualification, onboarding, and performance management activities.

Conduct supplier audits and assessments to evaluate manufacturing capabilities, process controls, and quality management systems.

Develop supplier improvement plans and monitor progress against established metrics.

Establish and maintain supplier scorecards for quality, delivery, responsiveness, and cost performance.

Support supplier risk assessments and mitigation activities.

PPAP & Process Validation

Lead and review Production Part Approval Process (PPAP) submissions for new and existing suppliers.

Review and approve key PPAP documentation including:

Process Flow Diagrams

PFMEA (Process Failure Mode and Effects Analysis)

Control Plans

Measurement System Analysis (MSA)

Capability Studies (Cp/Cpk)

First Article Inspection Reports (FAIR)

Dimensional Results

Material Certifications

Ensure process validations and manufacturing controls are implemented and maintained by suppliers.

Collaborate with suppliers to resolve PPAP deficiencies and qualification issues.

Quality Assurance & Compliance

Ensure supplier compliance with ISO 13485 requirements and applicable regulatory standards.

Support supplier quality activities associated with medical device manufacturing and applicable regulatory requirements.

Participate in internal and external audits as subject matter expert for supplier quality processes.

Ensure supplier documentation, records, and quality systems meet company and regulatory expectations.

Support change control activities including supplier process changes, material changes, and manufacturing transfers.

Corrective and Preventive Actions

Lead root cause investigations using methodologies such as:

8D

5 Why

Fishbone Analysis

Fault Tree Analysis

Drive supplier corrective and preventive action (CAPA) effectiveness.

Verify implementation and sustainability of corrective actions.

Escalate recurring supplier quality issues as appropriate.

Continuous Improvement

Identify and implement supplier process improvements that enhance quality, reliability, capacity, and cost.

Utilize Lean Manufacturing and Six Sigma tools to drive continuous improvement initiatives.

Collaborate with Engineering, Operations, Procurement, and Quality teams to reduce risk and improve supplier performance.

Support cost reduction and value engineering initiatives.