Supplier Quality Engineer — APQP & Process Validation

JobDiva, Inc.; Bedford (MA); On-site; USD 95,000 - 130,000; Full time

Job summary

JobDiva, Inc. is seeking a Manufacturing Quality Engineer to drive APQP, supplier qualification audits, and continuous improvement across a critical supplier base. You will work with cross-functional teams to ensure design-for-manufacturability and robust process validation across medical-grade parts.

The role requires 3+ years in manufacturing quality, knowledge of IQ/OQ/PQ, and ISO 13485 familiarity. You will engage suppliers, manage changes, and lead corrective actions to achieve zero-defect

Qualifications

• Bachelor's degree in engineering is required; Master’s degree is a plus.
• 3+ years engineering experience in manufacturing/quality roles.
• Strong knowledge of APQP, QMS, and supplier quality processes.

Responsibilities

• Achieve high-quality performance at supplier partners via APQP, supplier qualification audits, and change management.
• Collaborate with Product Engineering, Supply Chain, Production and suppliers to implement supply chain strategies.
• Perform Process Validation and Verification across Spectrawave IGTD portfolios for consoles and catheter parts.
• Support DFMA, PFMEA, and design-for-manufacturability activities with R&D and Quality Design Assurance.
• Lead process validation plans and equipment qualifications with suppliers and drive continuous improvements.
• Investigate defects to determine supplier involvement and manage corrective actions (SCAR).
• Monitor supplier performance, trends, and quality issues to prevent defects in components and assemblies.
• Oversee supplier-initiated change requests (SICRs) with regulatory review and validation.

Skills

APQP

SCAR process

DFMA/PFMEA

Quality Assurance

IQ/OQ/PQ

Cross-functional

Education

Bachelor's degree in Engineering

Master's degree (plus)

Job description

JobDiva, Inc. is seeking a Manufacturing Quality Engineer to drive APQP, supplier qualification audits, and continuous improvement across a critical supplier base. You will work with cross-functional teams to ensure design-for-manufacturability and robust process validation across medical-grade parts.

The role requires 3+ years in manufacturing quality, knowledge of IQ/OQ/PQ, and ISO 13485 familiarity. You will engage suppliers, manage changes, and lead corrective actions to achieve zero-defect