Lead Process Validation & Supplier Quality Engineer

JobDiva, Inc.; Bedford (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

JobDiva, Inc. in Bedford, MA is seeking a senior Manufacturing Quality Engineer to lead APQP, supplier qualification, and continuous monitoring to achieve zero defects in critical IGTD components.

You will partner with Product Engineering, Supply Chain, Production and suppliers to design robust processes and implement effective quality plans. You should have a bachelor’s degree in engineering, 10+ years in manufacturing or product quality, and leadership experience resolving non-conformances.

Qualifications

• Bachelor's degree in engineering; master's preferred.
• 10+ years of relatable engineering experience (Manufacturing or Product Quality).
• 5+ years of leadership resolving non-conformance and manufacturing validation.
• Subject Matter Expert in IQ, OQ, PQ.
• SO 13485 Lead Auditor certification is a plus.
• Experience with plastic, metal, electronics parts/commodities.
• Strong written, oral and interpersonal skills; travel ~20%.

Responsibilities

• Perform Process Validation and Verification across IGTD portfolios for consoles and catheter parts.
• Collaborate with R&D and Quality Design Assurance in DFMAE and PFMEA.
• Perform PV, V&V and assess CTS/CTQ per APQP for +700 parts.
• Support Supplier Qualification including Audit, Quality Agreement and Change Notice Agreement.
• Lead problem solving in FAI and APQP failure.
• Deep dive Value Stream mapping across processes.
• Investigate defects to determine supplier cause and implement SCAR corrections.
• Proactively manage supplier-related quality issues and monitor trends.

Skills

Leadership

Cross-functional

Communication

Problem solving

Education

Bachelor's degree in engineering

Master's degree preferred

Tools

IQ/OQ/PQ

Job description

JobDiva, Inc. in Bedford, MA is seeking a senior Manufacturing Quality Engineer to lead APQP, supplier qualification, and continuous monitoring to achieve zero defects in critical IGTD components.

You will partner with Product Engineering, Supply Chain, Production and suppliers to design robust processes and implement effective quality plans. You should have a bachelor’s degree in engineering, 10+ years in manufacturing or product quality, and leadership experience resolving non-conformances.