Systems Engineering Analyst

Position Summary
Responsible for equipment compliance with applicable regulatory requirements. Ensure adherence to Good Documentation Practices (GDP) for paper and electronic records generated in asset lifecycle management for managed equipment/assets. Includes authoring/review of instrument reports, GDP corrections, ensuring data integrity in applicable electronic platforms, and final quality signoff for work orders/verifications.

Job Responsibilities
- Ensure equipment verification record compliance (CLIA, NYS, CAP, ISO, FDA, IVDR, etc.).
- Assist with clinical requalification of instrumentation to maintain regulatory compliance and efficiency.
- Author cross-correlation reports for Molecular, IHC, and liquid profiling workflows.
- Ensure requalification paperwork is reviewed/approved timely.
- Review records for accuracy and GDP.
- Define/execute projects within validation programs by analyzing system/process dependencies (lab instrumentation, operations, IT, Quality).
- Support internal/external audits (preparation, responses, documentation).
- Support asset lifecycle management activities.
- Author, review, revise, and implement SOPs.
- Manage company records per regulatory requirements and company policies.
- Cross-functionally collaborate with Systems Engineering, Laboratory, IT, Software QA, and Quality.

Required Qualifications
- Bachelor’s degree in engineering, biological science, computer science, or similar.
- Strong knowledge of QMS requirements (CAP/CLIA, ISO 13485, 21 CFR Part 820).
- 1 year experience in a regulated laboratory environment.
- Proficient in Microsoft Office (Word, Excel, Outlook) and basic business Internet use.

Preferred Qualifications
- Lean Six Sigma certified.
- 2 years regulated lab experience focused on instrumentation/equipment.
- Master’s degree in relevant field.