Product Quality Engineer

Katalyst Healthcares & Life Sciences

Greenville, SC

Apply

JOB DETAILS

SKILLS

8D, Aerospace and Defense, Analysis Skills, Biomedical Engineering, Biotech and Pharmaceutical, Change Control, Chemical Engineering, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer/Client Research, Design Failure Mode and Effects Analysis (DFMEA), Design Verification, Electrical Engineering, Electronics, Failure Mode and Effects Analysis (FMEA), Industrial Engineering, Industry Standards, Lean Manufacturing, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Engineering, Manufacturing Operations, Mechanical Engineering, Medical Equipment, Minitab, Performance Metrics, Problem Solving Skills, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Validation, Product Development, Product Engineering, Product Lifecycle, Product Support, Product/Service Launch, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Risk Analysis, Risk Management, Root Cause Analysis, Statistics, Supply Chain Operations, Team Player, Technical/Engineering Design

LOCATION

Greenville, SC

POSTED

10 days ago

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.
3 8+ 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.

Product Quality Engineer

Katalyst Healthcares & Life Sciences

Greenville, SC

Requirements:

About the Company

Katalyst Healthcares & Life Sciences

Similar Job Searches