Product Quality Engineer

Responsibilities

• Support product quality activities throughout the product lifecycle, including design, development, manufacturing, and sustaining engineering.
• Develop and implement quality plans, inspection criteria, and product acceptance requirements.
• Collaborate with Design Engineering, Manufacturing, Operations, Supply Chain, and Regulatory teams to ensure product quality objectives are achieved.
• Participate in New Product Introduction (NPI) and New Product Development (NPD) projects.
• Perform risk assessments using DFMEA, PFMEA, Risk Analysis, and Control Plans.
• Lead investigations for product quality issues using Root Cause Analysis tools such as 8D, 5 Whys, and Fishbone.
• Manage Non-Conformance Reports (Client), Corrective and Preventive Actions (CAPA), Deviations, and Change Controls.
• Analyze quality metrics, product performance, warranty data, and customer complaints to identify improvement opportunities.
• Support Design Verification (DV), Design Validation (PV), Process Validation (IQ/OQ/PQ), and product qualification activities.
• Ensure compliance with Quality Management Systems (QMS) and applicable regulatory standards.
• Review engineering changes and assess their impact on product quality.
• Work closely with Supplier Quality teams to resolve supplier-related quality issues.
• Perform statistical analysis using SPC, Cp/Cpk, MSA, Gauge R&R, and Minitab or similar tools.
• Support internal, customer, and regulatory audits.
• Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.

Requirements

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Manufacturing Engineering, Electrical Engineering, Chemical Engineering, or a related field.
• 38+ years of experience in Product Quality Engineering or Quality Assurance within a regulated manufacturing environment.
• Experience supporting product development and manufacturing quality activities.
• Strong knowledge of Quality Management Systems (QMS).
• Experience with CAPA, Client, Root Cause Analysis, FMEA, and Risk Management.
• Working knowledge of SPC, statistical analysis, and quality improvement methodologies.
• Excellent analytical, problem-solving, communication, and collaboration skills.