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QA Engineer: Validation, Compliance & CAPA Lead
Job in
Auburn, De Kalb County, Indiana, 46706, USA
Listed on 2026-02-01
Listing for:
C&A Tool
Full Time
position Listed on 2026-02-01
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Job Description & How to Apply Below
Responsibilities
- Lead and execute IQ/OQ/PQ validation activities for equipment, processes, and product introductions.
- Develop, review, and approve Validation Master Plans, protocols, and reports.
- Support Design/Product Transfer, New Product Introduction (NPI), and process optimization projects.
- Maintain compliance with ISO 13485, FDA 21 CFR Part 820, other applicable regulations/standards, and internal quality system procedures.
- Drive root cause investigations and implement effective Corrective and Preventive Actions (CAPA).
- Support internal audits, supplier audits, and regulatory inspections as needed.
- Analyze quality data trends and recommend improvements to reduce defects and nonconformances.
- Ensure lot traceability, documentation accuracy, and compliance with Device History Records (DHR).
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