Quality Engineer - Medical Devices, CAPA & Lean Improvement

Katalyst-Healthcares-; Utah; On-site; USD 70,000 - 95,000; Full time

Job summary

Creative Solutions Services, LLC in Salt Lake City, UT, is seeking an experienced Quality Engineer to support quality systems, investigations, compliance, and continuous improvement in a regulated medical-device manufacturing environment.

You will lead CAPA activities, perform root-cause analysis, maintain ISO 13485 compliance, and collaborate across manufacturing and engineering to drive improvements.

Qualifications

• Medical-device industry experience is mandatory.
• CAPA and Nonconformance management experience.
• Quality investigations and Root Cause Analysis.
• Strong Quality Management Systems knowledge.
• ISO 13485 experience.
• FDA QMSR / 21 CFR Part 820 knowledge.
• Continuous improvement and process-improvement experience.
• Lean Manufacturing / Six Sigma knowledge.
• Experience working within highly regulated manufacturing environments.

Responsibilities

• Manage and investigate nonconforming materials, products and processes
• Support the complete CAPA lifecycle, including investigation, documentation and effectiveness activities
• Conduct structured Root Cause Analysis (RCA) and problem-solving
• Maintain compliance with established Quality Management System requirements
• Support compliance with ISO 13485 and FDA 21 CFR Part 820 / QMSR requirements
• Identify and implement quality and manufacturing process improvements
• Apply Lean Manufacturing and Six Sigma methodologies to reduce defects and improve operational performance
• Support inspection-ready documentation and quality records
• Collaborate with manufacturing, engineering and other cross-functional teams to resolve quality issues

Skills

CAPA Management

Nonconformance Mgmt

Root Cause Analysis

Quality Investigations

Quality Management Systems

ISO 13485

FDA QMSR 21 CFR 820

Lean Manufacturing

Six Sigma

Regulated manufacturing

Job description

Summary:
An opportunity is available for an experienced Quality Engineer to support quality systems, investigations, compliance, and continuous improvement within a regulated medical-device manufacturing environment.

Roles & Responsibilities:

• Manage and investigate nonconforming materials, products and processes
• Support the complete CAPA lifecycle, including investigation, documentation and effectiveness activities
• Conduct structured Root Cause Analysis (RCA) and problem-solving
• Maintain compliance with established Quality Management System requirements
• Support compliance with ISO 13485 and FDA 21 CFR Part 820 / QMSR requirements
• Identify and implement quality and manufacturing process improvements
• Apply Lean Manufacturing and Six Sigma methodologies to reduce defects and improve operational performance
• Support inspection-ready documentation and quality records
• Collaborate with manufacturing, engineering and other cross-functional teams to resolve quality issues

Qualification:

• Medical-device industry experience is mandatory
• CAPA and Nonconformance Management experience
• Quality investigations and Root Cause Analysis
• Strong Quality Management Systems knowledge
• ISO 13485 experience
• FDA QMSR / 21 CFR Part 820 knowledge
• Continuous improvement and process-improvement experience
• Lean Manufacturing / Six Sigma knowledge
• Experience working within highly regulated manufacturing environments