Senior QA Specialist - Medical Devices & Documentation

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

Benefits offered by this job

Free medical coverage (HIP PPO)

Excellent retirement savings plan

Tuition reimbursement

FreeU education benefit

Great workplace reputation

Job summary

Abbott Laboratories in Westfield, IN is seeking a QA Specialist III to ensure manufactured and sterilized units meet internal procedures before release. The role operates 3:00pm–11:30pm, Mon–Fri, with occasional Saturdays.

You will review lots, track docs, quarantine nonconformities, and release products in SAP after DHF validation. The ideal candidate has a High School Diploma/GED with 4+ years in a quality system environment and demonstrates strong problem-solving and leadership for continuous

Qualifications

• Requires High School Diploma or GED with 4+ years related experience.
• Experience in a quality system environment and complex assignments.
• Strong judgment, initiative, creativity, and leadership for troubleshooting and improvements.
• Prior experience handling documentation, reviews, and compliance.

Responsibilities

• Reviews Manufacturing documentation and lot history records per internal procedures.
• Tracks documentation discrepancies and trends.
• Notifies Manufacturing of issues and communicates formally about discrepancies.
• Maintains a quarantine area for discrepant materials until resolution.
• Releases product in SAP within the sterile cycle after approvals and DHF validation.
• Reviews and approves Design History Files and Engineering Orders for release.
• Advises Manufacturing and project leaders as the expert on documentation compliance.
• Coordinates clinical product release to approved sites.
• Audits materials and work through inspection and testing of raw materials and documentation.

Skills

Leadership

Quality systems

Documentation

Troubleshooting

Continuous improvement

Education

High School Diploma / GED

Associates Degree or some college credits

Job description

Abbott Laboratories in Westfield, IN is seeking a QA Specialist III to ensure manufactured and sterilized units meet internal procedures before release. The role operates 3:00pm–11:30pm, Mon–Fri, with occasional Saturdays.

You will review lots, track docs, quarantine nonconformities, and release products in SAP after DHF validation. The ideal candidate has a High School Diploma/GED with 4+ years in a quality system environment and demonstrates strong problem-solving and leadership for continuous