Product Quality Engineer

Katalyst CRO; Greenville (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in Greenville, SC is seeking a Product Quality Engineer to ensure product quality throughout the lifecycle from design to post-market support. You will collaborate with Design, Manufacturing, Regulatory, and Supply Chain teams to implement quality plans, perform risk assessments, and drive CAPA and continuous improvement using SPC and Six Sigma.

If you have a strong background in QMS, CAPA, and root cause analysis and enjoy cross-functional problem solving, this role offers growth

Qualifications

• Bachelor's degree in engineering or related field.
• 38+ years of experience in Product Quality Engineering or QA in a regulated manufacturing environment.
• Experience supporting product development and manufacturing quality activities.
• Strong knowledge of QMS and regulatory standards.
• Experience with CAPA, Root Cause Analysis, FMEA, and Risk Management.
• Working knowledge of SPC and quality improvement methodologies.
• Excellent analytical, problem‑solving, communication, and collaboration skills.

Responsibilities

• Support 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.
• Participate in NPI and NPD projects.
• Perform risk assessments using DFMEA, PFMEA, Risk Analysis, and Control Plans.
• Lead investigations for quality issues using 8D, 5 Whys, and Fishbone.
• Manage Non‑Conformance Reports, CAPA, Deviations, and Change Controls.
• Analyze quality metrics and warranty data to identify improvements.
• Support DV, PV, IQ/OQ/PQ, and product qualification activities.
• Ensure compliance with QMS and regulatory standards.
• Review engineering changes and assess impact on quality.
• Work with Supplier Quality to resolve supplier quality issues.
• Perform statistical analysis using SPC, Cp/Cpk, MSA, Gauge R&R, and Minitab.
• Support audits and drive Lean Six Sigma improvement initiatives.

Skills

Root Cause Analysis

CAPA

Quality Assurance

Statistical Analysis

Lean Six Sigma

Cross-functional Collaboration

Documentation

Auditing

Risk Management

Process Improvement

Education

Engineering degree

Tools

Minitab

SPC Software

Quality Management System (QMS)

Job description

Job Description

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.