Senior Onsite Supplier Quality Engineer – Medical Devices

Regulatory Jobs; Bedford (MA); Presencial; USD 103.000 - 163.000; Jornada completa

Descripción de la vacante

Philips is seeking a Senior Supplier Quality Engineer to join the Image Guided Therapy Devices (IGTD) Quality team in Bedford, MA. The role drives supplier performance, APQP and process validation while ensuring regulatory compliance across the product lifecycle.

You will oversee supplier audits, NC/SCAR management, data-driven quality improvements, and interface with Regulatory Agencies and Notified Bodies.

Formación

• 5+ years in Supplier Quality Engineering within FDA-regulated medical device environments (supplier selection, performance assessment, APQP, Risk Assessments/PFMEA, SPC, SCAR, SICR, CAPA, Remediation).
• Knowledge of medical device regulations and standards: 21 CFR Parts 803/806/820, ISO 13485, ISO 14971, EU MDR, EU Medical Device Regulation, Canadian MDR.
• Ability to analyze data/KPIs to drive process improvements and assess supplier performance; strong cross-functional communication skills.
• Bachelor’s Degree in Quality/Engineering or related field is required; ASQ Six Sigma (DFx) certifications are desirable.

Responsabilidades

• Coordinate and drive supplier improvement initiatives and manage Approved Supplier List; negotiate Supplier Quality Agreements.
• Provide sustaining SQE activities handling NCRs/SCARs/SCNs and ASL; manage APQP with suppliers.
• Facilitate supplier capability assessments and supplier selection; monitor quality performance trends.
• Lead end-to-end performance management of suppliers; determine supplier-caused defects; act as reviewer for Supplier Corrective Actions (SCARs).
• Develop and oversee equipment qualification and process validation plans; lead continuous improvement projects based on trends and regulatory needs.
• Provide Quality oversight of supplier change requests with regulatory validation; audit planning, execution, reporting and closure.

Conocimientos

Supplier Quality Eng

APQP

PFMEA

SPC

SCAR

CAPA

Data analytics

Cross-functional comms

Regulatory knowledge

Educación

Bachelor's Degree in Quality/Engineering

Herramientas

ASQ Six Sigma

Descripción del empleo

Philips is seeking a Senior Supplier Quality Engineer to join the Image Guided Therapy Devices (IGTD) Quality team in Bedford, MA. The role drives supplier performance, APQP and process validation while ensuring regulatory compliance across the product lifecycle.

You will oversee supplier audits, NC/SCAR management, data-driven quality improvements, and interface with Regulatory Agencies and Notified Bodies.