Product Quality Engineer

We are seeking a Product Quality Engineer to ensure product quality throughout the entire product lifecycle, from design and development through manufacturing and post-market support. The ideal candidate will collaborate with cross-functional teams to establish quality requirements, drive continuous improvement, investigate product quality issues, and ensure compliance with industry and regulatory standards. This role is ideal for candidates with experience in medical devices, pharmaceuticals, automotive, aerospace, electronics, or general manufacturing.

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.