Senior Supplier Quality Engineer - Process Validation APQP

PayCruit; Bedford (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

PayCruit is seeking a Sr. Supplier Quality Engineer in Bedford, MA to lead process validation and supplier qualification programs for a broad parts portfolio.

You will partner with R&D, design, and production teams to prevent defects and drive supplier performance improvements across plastics, metals, and electronics. The ideal candidate has a 3+ year engineering background in manufacturing or product quality, knowledge of APQP, PFMEA, and CTS/CTQ criteria, and a track record of problem solving

Qualifications

• Bachelor's degree in engineering; Master preferred.
• 3+ years engineering experience in manufacturing or product quality.
• Experience in process validation and verification (IQ/OQ/PQ).
• SO 13485 Lead Auditor certification is a plus.
• Experience with plastics, metal, and electronics.

Responsibilities

• 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.

Skills

Process Validation

APQP

Supplier Quality

Problem Solving

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Master's degree preferred

Job description

PayCruit is seeking a Sr. Supplier Quality Engineer in Bedford, MA to lead process validation and supplier qualification programs for a broad parts portfolio.

You will partner with R&D, design, and production teams to prevent defects and drive supplier performance improvements across plastics, metals, and electronics. The ideal candidate has a 3+ year engineering background in manufacturing or product quality, knowledge of APQP, PFMEA, and CTS/CTQ criteria, and a track record of problem solving