Documentation Specialist

4 weeks ago

Latham, United States Integrated Resources, Inc ( IRI ) Full time

Job Description:

The QA Specialist – DHR Reviewer is a member of the Manufacturing Quality team within the Philips MRI magnet manufacturing facility in Latham, NY. This is an onsite role which ensures compliance with legal, regulatory and international standards as they apply to Latham’s Quality Management System. This individual ensures Device History Records meet regulatory and internal requirements and provide adequate verification of compliance to the product’s engineering specifications.


In this role you are responsible for:

  • Reviewing and approving of executed DHR packages (electronic & paper record) and ensuring the data is in compliance with relevant specifications, parameters and tolerances in accordance with local procedures, regulatory requirements and international standards.
  • Reviewing data recorded in the Manufacturing Execution System (MES) to ensure compliance with relevant specifications, parameters and tolerances in accordance with local procedures, regulatory requirements, and international standards.
  • Identifying areas for improvement within DHR process and data collection to optimize execution and efficiency.
  • Executing in-line DHR reviews to proactively identify risks or nonconformances.
  • Identifying non-conformances and taking appropriate actions to correct issues through Non-conforming Process.
  • Reviewing proposed or revised DHR data collects to ensure compliance with relevant specifications, local procedures, regulatory requirements and international standards.
  • Supporting nonconformance investigations, as required, to drive root cause and corrective actions in Operations.
  • Providing Quality Engineers with support and data, as needed, to improve Quality on manufactured products.


To succeed in this role, you should have the following skills and experience.

  • Technician Diploma or bachelor’s degree in engineering science or equivalent work experience.
  • 1+ years Quality Assurance experience in medical device or regulated industry, preferred.
  • Proficient in Good Documentation Practices (GDP).
  • General understanding of ISO 9001, ISO 13485, FDA CFR 21 part 820, and Good Manufacturing Practices (GMP).
  • Must understand the concept of traceability (product, material, and calibration).
  • Strong communication skills including written, verbal and listening skills.
  • Strong organizational skills, ability to multi-task and effectively prioritize your workload.
  • Microsoft office proficiency a must – specifically, Word, Excel, PowerPoint, Visio and Outlook.
  • Direct experience using eQMS and ERP software (e.g., Trackwise, EtQ, SAP) desired.

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