QC Analyst II -

Overview

Our client, a global leader in medical device manufacturing, is seeking a Quality Control Analyst II to support quality operations at their Warsaw, IN facility. This role is critical in ensuring product quality, regulatory compliance, and audit readiness through the accurate review, analysis, and approval of manufacturing documentation. The ideal candidate brings strong analytical skills, deep attention to detail, and experience working within regulated environments.

Key Responsibilities

• Review and approve Device History Records (DHRs) to ensure accuracy, completeness, and compliance with FDA, ISO, and internal Quality System requirements.

• Perform daily batch record reviews to verify adherence to SOPs, product specifications, and GMP standards.

• Identify documentation errors, discrepancies, and non‑conformances; initiate investigations and support root‑cause analysis as needed.

• Partner with Manufacturing, Quality Engineering, Quality Assurance, and Supply Chain to resolve documentation issues and ensure timely record closure.

• Maintain audit readiness by ensuring all quality records are accurate, complete, and properly archived.

• Participate in CAPA, deviation management, and change control processes.

• Contribute to continuous improvement initiatives focused on documentation accuracy, workflow efficiency, and compliance.

• Uphold strong documentation practices in alignment with Good Documentation Practices (GDP).

Required Qualifications

• 1-3+ years of experience in a quality role within medical device, pharmaceutical, or other regulated manufacturing environments.

• Hands‑on experience with DHR review and batch record review.

• Working knowledge of GMP/GDP, 21 CFR Part 820, and ISO 13485.

• Strong analytical skills with the ability to identify errors, trends, and inconsistencies.

• Effective communication skills with the ability to collaborate across departments.

• Experience in a

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.