Onsite Quality Engineer II - Medical Device

ManpowerGroup; Austin (TX); On-site; USD 45,000 - 50,000; Full time

Job summary

ManpowerGroup is seeking an Engineer - Degreed II to join a Fortune 500 client in Austin, on-site. This role focuses on supporting day-to-day Quality Operations in a medical device manufacturing environment, ensuring GMP and ISO 13485 compliance.

The ideal candidate has a Bachelor's in engineering or related field and at least 3 years of quality experience, with hands-on exposure to DHRs, CAPAs, NCRs, change control, and process improvements.

Qualifications

• Bachelor's degree in engineering/science or related field.
• Minimum 3+ years in Operations Quality or Quality Engineering in medical device/pharma manufacturing.
• Hands-on experience in cleanroom and laboratory environments preferred.

Responsibilities

• Support day-to-day Quality Operations in a medical device manufacturing environment.
• Act as Customer Ops QA representative interfacing with Third-Party Manufacturer (TPM).
• Provide oversight of quality records: NCRs, CAPAs, change control, validations, supplier changes, DHRs.
• Review and ensure compliant resolution of nonconformances and CAPAs.
• Lead/support quality investigations and perform root cause analysis.
• Ensure adherence to GMP, FDA, ISO 13485, and QMS requirements.
• Review Device History Records (DHRs) and support product release activities.
• Partner with manufacturing and engineering to resolve defects and improve processes.
• Monitor and report quality KPIs and trends.
• Support deviations, validations, and supplier change activities.
• Identify and drive continuous improvement initiatives.
• Ensure TPM maintains compliance with quality system requirements.
• Author/review quality documentation and investigation reports.

Skills

Quality Operations

Quality Engineering

Medical device manufacturing

CAPA

NCRs

DHRs

GMP

FDA

ISO 13485

Root cause analysis

Continuous improvement

Education

Bachelor's degree in Engineering/Science

Tools

Quality Management System (QMS)

CAPA system

DHR review tools

Job description

ManpowerGroup is seeking an Engineer - Degreed II to join a Fortune 500 client in Austin, on-site. This role focuses on supporting day-to-day Quality Operations in a medical device manufacturing environment, ensuring GMP and ISO 13485 compliance.

The ideal candidate has a Bachelor's in engineering or related field and at least 3 years of quality experience, with hands-on exposure to DHRs, CAPAs, NCRs, change control, and process improvements.