Senior Supplier Quality Engineer, Medical Devices

Katalyst CRO; Newark (DE); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking a Senior Supplier Quality Engineer to oversee supplier quality activities for components, materials, and services. You will ensure suppliers meet regulatory and business requirements and collaborate with R&D, Design Assurance, and manufacturing teams.

The role requires deep knowledge of medical device regulations, CAPA, PPAP, and statistical methods to prevent failures and improve processes. Extensive cross-functional interaction and effective documentation are essential.

Qualifications

• Bachelor's degree in Engineering or related field required.
• ISO 13485 Lead Auditor certification required.
• Strong knowledge of Medical Device Regulations (FDA CFR 820, ISO 13485, ISO 14971, ISO 9001).
• Experience with CAPA, IQ/OQ/PQ validations, GR&R, and SPC.

Responsibilities

• Provide oversight of supplier quality, ensuring materials and services meet regulatory and business requirements.
• Perform supplier technical reviews to assess capability to manufacture materials/components.
• Oversee supplier manufacturing processes, QC practices, corrective actions, and FAI.
• Define/approve PPAP requirements for new/revised parts.
• Collaborate with R&D and Design Assurance to ensure product quality and reliability.
• Manage supplier quality events (SCARs, SACAs, NCEs) with KPI tracking.
• Conduct root cause investigations and statistical analysis with suppliers.
• Coordinate cross-functional teams to resolve supplier-related issues.
• Maintain supplier quality records and generate performance reports.
• Onboard and implement new suppliers with qualified processes.
• Apply SPC, TQM, and statistical sampling to optimize processes.

Skills

Supplier quality

Regulatory compliance

Problem solving

Statistical analysis

Project management

Cross-functional teamwork

Documentation

Education

Bachelor's degree in Engineering

ISO 13485 Lead Auditor

Job description

Katalyst CRO is seeking a Senior Supplier Quality Engineer to oversee supplier quality activities for components, materials, and services. You will ensure suppliers meet regulatory and business requirements and collaborate with R&D, Design Assurance, and manufacturing teams.

The role requires deep knowledge of medical device regulations, CAPA, PPAP, and statistical methods to prevent failures and improve processes. Extensive cross-functional interaction and effective documentation are essential.