Systems Engineering Analyst

Role Summary

Position Summary

This position is responsible for equipment compliance with all applicable regulatory requirements. This role ensures adherence to Good Documentation Practices (GDP) in all paper and electronic records generated within asset lifecycle management for all managed equipment and assets. This includes assisting with the authoring and review of instrument reports, facilitation of corrections per GDP, ensuring data integrity across laboratory instrumentation records in applicable electronic platforms, and performing final quality signoff for work orders and verifications.

Responsibilities

• Ensure equipment verification record compliance with all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDR, etc.).
• Collaborate and assist in clinical requalification of instrumentation to maintain company-wide regulatory compliance and operational efficiency.
• Author cross-correlation reports for Molecular, IHC and liquid profiling workflows.
• Ensure requalification paperwork is reviewed and approved in a timely fashion.
• Review records for accuracy and Good Documentation Practices (GDP).
• Analyze system/process dependencies between laboratory instrumentation, operations, IT infrastructure, and Quality to define and execute projects within the validation programs.
• Participate in internal and external audits with tasks such as audit preparation, answering questions, and providing documentation to auditors.
• Support asset lifecycle management activities.
• Author, review, revise, and implement standard operating procedures (SOPs).
• Manage company records in accordance with regulatory requirements and company policies.
• Engage in cross-functional collaborations between Systems Engineering, Laboratory, IT, Software QA, and Quality teams to support program alignment between organizational and regulatory requirements.

Qualifications

• Required: Bachelor‚Äôs degree in engineering, biological science, computer science, or similar field
• Required: Strong knowledge of QMS requirements per CAP/CLIA, ISO 13485, and 21 CFR Part 820
• Required: One year of experience working in a regulated laboratory environment
• Required: Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use
• Preferred: Lean Six Sigma certified
• Preferred: Two years of experience working in a regulated laboratory environment with a focus on laboratory instrumentation and equipment
• Preferred: Master‚Äôs degree in engineering, biological science, computer science, or similar field

Skills

• Regulatory compliance
• Quality management systems (QMS)
• Laboratory instrumentation and equipment
• Documentation and record-keeping (GDP/SOPs)
• Cross-functional collaboration
• Audit preparation and response
• Project management within validation programs

Education

• Bachelor‚Äôs degree in engineering, biological science, computer science, or similar field

Additional Requirements

• This position requires some evenings, weekends and/or holidays