Senior QA Specialist — Sterile Medical Devices

Abbott; Westfield (IN); On-site; USD 22,000 - 44,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Retirement plan

Education benefits

Job summary

Abbott in Westfield, IN is hiring a QA Specialist III to ensure manufactured and sterilized units meet internal procedures before release. The role emphasizes documentation control, SDLC compliance, and collaboration with manufacturing teams in a 3:00pm-11:30pm schedule with potential Saturday overtime.

You will review lot history records, manage non-conforming materials, perform SAP transactions, and support Design History File approvals in a regulated healthcare environment.

Qualifications

• High School Diploma or GED required.
• Minimum 4 years related work experience.
• Solid knowledge of business concepts, procedures and practices.
• Quality system environment experience.
• Ability to perform complex assignments with judgment and initiative.

Responsibilities

• Review manufacturing documentation by obtaining lot history records and non-conforming material reports and ensure conformance.
• Track documentation discrepancies and maintain a mechanism to identify trends.
• Notify manufacturing personnel of documentation issues and inform formally on discrepancies.
• Confine discrepant materials in a quarantine area until resolution.
• Release product in SAP after Product Release Authorization and LHR review.
• Review and approve Design History Files and related EOs for archive release.
• Advise manufacturing personnel and project leaders as the documentation expert.
• Coordinate clinical product release paperwork to approved sites.
• Audit materials and the work of others through inspection, testing, and documentation.

Skills

Quality assurance

Documentation

Auditing

Problem solving

Regulatory awareness

Education

High School Diploma / GED

Tools

SAP

Job description

Abbott in Westfield, IN is hiring a QA Specialist III to ensure manufactured and sterilized units meet internal procedures before release. The role emphasizes documentation control, SDLC compliance, and collaboration with manufacturing teams in a 3:00pm-11:30pm schedule with potential Saturday overtime.

You will review lot history records, manage non-conforming materials, perform SAP transactions, and support Design History File approvals in a regulated healthcare environment.