Quality Engineer

Intellectt INC; Tempe (AZ); On-site; USD 85,000 - 110,000; Full time

Job summary

Intellectt INC is seeking an experienced Quality Engineer in Tempe, AZ to support quality assurance and manufacturing activities within a regulated medical device environment. The role focuses on maintaining product and process quality, investigating nonconformances, supporting CAPA activities, and ensuring ongoing compliance with applicable quality system requirements.

You will lead or support CAPA, NCR, SCAR and corrective actions; develop and maintain quality procedures, inspection plans, and

Qualifications

• Bachelor's degree in Engineering, Science, Quality or related field.
• 3–5+ years of Quality Engineering in medical device industry.
• Strong experience with CAPA, NCR, root cause analysis, and nonconformance investigations.
• Working knowledge of ISO 13485 and FDA Quality System requirements.
• Experience with risk management and quality documentation.
• Strong analytical, problem-solving and technical writing skills.
• Ability to work in a cross-functional, regulated manufacturing environment.

Responsibilities

• Support day-to-day quality engineering activities for medical device manufacturing.
• Investigate nonconformances, deviations, complaints and quality issues and perform root cause analysis.
• Lead or support CAPA, NCR, SCAR and corrective action activities.
• Develop and maintain quality procedures, work instructions, inspection plans, and related documentation.
• Support process validation, equipment qualification, and process improvement activities.
• Perform risk assessments and support product/process changes through change control.
• Analyze quality data and identify trends and opportunities for improvement.
• Support internal, supplier, and regulatory audits as required.
• Partner with Manufacturing, Engineering, R&D, Regulatory, and Operations teams to resolve quality issues.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and applicable company quality procedures.

Skills

CAPA

NCR

Root Cause Analysis

Nonconformance Investigations

Education

Bachelor's degree in Engineering/Science/Quality

Tools

ISO 13485

FDA Quality System

Job description

Title : Quality Engineer

Location: Tempe, Arizona
Experience: 3 5+ years
Industry: Medical Device

Position Summary

We are seeking an experienced Quality Engineer to support quality assurance and manufacturing activities within a regulated medical device environment. The role will focus on maintaining product and process quality, investigating nonconformances, supporting CAPA activities, and ensuring compliance with applicable quality system requirements.

Key Responsibilities

• Support day-to-day quality engineering activities for medical device manufacturing.
• Investigate nonconformances, deviations, complaints, and quality issues and perform root cause analysis.
• Lead or support CAPA, NCR, SCAR, and corrective action activities.
• Develop and maintain quality procedures, work instructions, inspection plans, and related documentation.
• Support process validation, equipment qualification, and process improvement activities.
• Perform risk assessments and support product/process changes through change control.
• Analyze quality data and identify trends and opportunities for improvement.
• Support internal, supplier, and regulatory audits as required.
• Partner with Manufacturing, Engineering, R&D, Regulatory, and Operations teams to resolve quality issues.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and applicable company quality procedures.

Required Qualifications

• Bachelor s degree in Engineering, Science, Quality, or a related technical field.
• 3 5+ years of Quality Engineering experience in the medical device industry.
• Strong experience with CAPA, NCR, Root Cause Analysis, and nonconformance investigations.
• Working knowledge of ISO 13485 and FDA Quality System requirements.
• Experience with risk management and quality documentation.
• Strong analytical, problem-solving, and technical writing skills.
• Ability to work effectively in a cross-functional, regulated manufacturing environment.