Supplier Quality Engineer

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

Roles and Responsibilities:

• Responsible for achieving a state of high-quality performance at our Supplier partners through the application and practice of Advanced Product Quality Planning 'APQP' , Supplier Qualification (Audit, Quality Agreement/Change Notice Agreement), and continuous monitoring the performance supplier to drive zero defect through Supplier Corrective Actions and notification.
• You will fill a high-profile, cross functional position and play an integral role enabling development and production flow of Philips IGTD's critical supply base.
• You will work in close coordination with Product Engineering, Supply Chain and Production and Suppliers to execute effective, creative and smart supply chain strategies to achieve production goals.
• Perform Process Validation and Verification across Spectrawave IGTD portfolios for Consoles and Catheter parts.
• Collaborate with R&D and Quality Design Assurance in Design for Manufacturability and Part Risk management per DFMAE and PFMEA.
• Perform Process Validation , Verification, Test Method Validation, and assess CTS/CTQ criteria per APQP requirement for +700 parts.
• Support Supplier Qualification including Audit, Quality Agreement and Change Notice Agreement.
• Perform Problem solving in the case of FAI and APQP failure.
• Deep dive Value Stream mapping across process.
• Conducts thorough investigations of defects to determine if they are supplier-caused and implement corrections using the SCAR process.
• Proactively manage, monitor, and troubleshoot supplier-related issues for quality of components, sub-assemblies, and assemblies including monitoring trends and managing Supplier Improvement and Supplier Quality Performance Monitoring.
• Providing Quality oversight of product/process change requests from suppliers (SICRs: Supplier Initiated Chage Requests), ensuring appropriate regulatory review and adequate validation to support requested changes including following our APQP process and leading process validation, as necessary
• Develop and oversee process validation plans, including equipment qualifications, with suppliers and lead continuous improvement projects based on process/product trends, customer complaints, industry standards, and government regulations.

Education and Experience:

• Bachelor's degree engineering (Master Degree is plus).
• 3+ years of engineering experience (Manufacturing Engineer and/or Product Quality is plus).
• In-depth product manufacturing and quality experience in process validation and verification Subject Matter in IQ, OQ, PQ
• SO, 13485 Lead Auditor certified is plus.
• Experienced in plastic, metal, electronics commodities.
• Strong written, oral and interpersonal skills to be able to effectively interface interdepartmentally and complete assignments with accuracy and a high attention to detail