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Product Quality Engineer

Greenville, SC, US • Posted 30+ days ago • Updated 5 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Functional Requirements
Medical Devices
Pharmaceuticals
Aerospace
Electronics
Inspection
Manufacturing Operations
Supply Chain Management
New Product Introduction
NPI
Risk Assessment
Risk Analysis
Management
DV
IQ
OQ
PQ
Regulatory Compliance
Minitab
Auditing
Continuous Improvement
Lean Manufacturing
Six Sigma
Mechanical Engineering
Industrial Engineering
Biomedical Engineering
Manufacturing Engineering
Electrical Engineering
Chemical Engineering
Quality Assurance
Product Development
Manufacturing
Quality Management
QMS
Corrective And Preventive Action
Root Cause Analysis
FMEA
Risk Management
Statistical Process Control
Statistics
Quality Improvement
Analytical Skill
Conflict Resolution
Problem Solving
Communication
Collaboration

Functional Requirements
Medical Devices
Pharmaceuticals
Aerospace
Electronics
Inspection
Manufacturing Operations
Supply Chain Management
New Product Introduction
NPI
Risk Assessment
Risk Analysis
Management
DV
IQ
OQ
PQ
Regulatory Compliance
Minitab
Auditing
Continuous Improvement
Lean Manufacturing
Six Sigma
Mechanical Engineering
Industrial Engineering
Biomedical Engineering
Manufacturing Engineering
Electrical Engineering
Chemical Engineering
Quality Assurance
Product Development
Manufacturing
Quality Management
QMS
Corrective And Preventive Action
Root Cause Analysis
FMEA
Risk Management
Statistical Process Control
Statistics
Quality Improvement
Analytical Skill
Conflict Resolution
Problem Solving
Communication
Collaboration

Summary

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.
nalyze 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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 6ad7ed1b2a774f1908384c21abdbf931
Posted 30+ days ago

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