Engineer - Degreed II

Abbott; Austin (TX); On-site; USD 41,000 - 58,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

Critical Illness, Hospital coverage,/

MetLife Legal, MetLife ID Fraud, and/

401(k)

Job summary

Abbott is seeking an Engineer - Degreed II for an on-site 9-month assignment in Austin, TX. You will support day-to-day Quality Operations in a medical device manufacturing environment and interface with the TPM as a Customer Ops QA representative.

This role requires hands-on experience with NCRs, CAPAs, DHRs and change controls, and a strong focus on GMP, FDA, ISO 13485, and QMS adherence. You will collaborate with manufacturing and engineering to resolve defects and drive continuous

Qualifications

• Bachelor's degree in engineering, science or related discipline or equivalent experience.
• Minimum 3+ years in Operations Quality or Quality Engineering for medical devices/pharma.
• Hands-on experience in cleanroom and laboratory environments.

Responsibilities

• Support day-to-day Quality Operations in a medical device manufacturing environment.
• Act as Customer Ops QA representative interfacing with TPM.
• Review and ensure compliant resolution of NCRs, CAPAs, changes, and DHRs.
• Lead/support quality investigations and perform root cause analysis.
• Ensure adherence to GMP, FDA, ISO 13485, and QMS requirements.
• Review 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

Root Cause Analysis

CAPA

Education

Bachelor's degree

Job description

Title: Engineer - Degreed II

Location: Austin, TX

Duration: 9 Months

100% Onsite

Shift Time: 8:00 am – 4:00 pm

Job Responsibilites:

• 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

Education:

• Bachelor's degree (preferably in Engineering, science or a closely related discipline is desired) or equivalent technical experience and demonstrated competence.


• Minimum 3+ years of work experience in an Operations Quality or Quality Engineering role supporting medical device or pharmaceutical manufacturing.


• Hands-on experience working in cleanroom and laboratory environments is preferred.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans


• Dental Plan


• Vision Plan


• Health Savings Account (for High-Deductible Health Plans)


• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)


• Supplemental Life Insurance


• Short Term Disability (coverage varies by state)


• Long Term Disability


• Critical Illness, Hospital coverage, Accident Insurance


• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance


• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.