Systems Engineer Jobs

About The Position

Requirements

• BS/MS in Engineering, Life Sciences, or a related field
• 3+ years of experience in a quality systems role in a regulated industry, ideally medical devices
• Working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485
• Proficiency with Microsoft Excel, Word, and Visio (or ability to learn quickly)
• Strong verbal and written communication skills
• Experience in project coordination and technical writing

Nice To Haves

• Strong technical writing skills: you can translate complex concepts clearly for diverse audiences.
• A natural curiosity and ability to quickly grasp technical systems, workflows, and requirements.
• Clear, confident communication: you know how to explain problems and solutions across a range of technical backgrounds.
• Solid project coordination and follow-through: you’re organized, dependable, and keep work moving forward.
• A proactive problem-solver mindset: you ask the right questions, challenge assumptions, and help teams find solutions.
• Collaborative energy: you contribute, share ideas, and maintain a constructive, can-do attitude.
• Precision and attention to detail: your work is thorough and consistent.
• Reliability: you take ownership, meet deadlines, and follow through.

Responsibilities

• Own and manage the end-to-end CAPA process, from intake and triage through investigation, root cause analysis, corrective/preventive action planning, and effectiveness verification.
• Facilitate cross-functional CAPA review meetings, ensuring teams identify systemic issues and align on appropriate remediation strategies.
• Ensure each CAPA is supported with objective evidence, clear problem statements, and traceability to impacted processes, products, or quality records.
• Maintain CAPA documentation in alignment with regulatory expectations, ensuring timely closure, audit readiness, and linkage to risk management where applicable.
• Monitor CAPA trends and performance metrics to identify recurring issues and drive continuous improvement.
• Support training and mentorship of team members on CAPA expectations, best practices, and root cause analysis tools.
• Own the development and revision of Standard Operating Procedures (SOPs) and associated change controls to ensure they align with regulatory requirements and support QMS compliance.
• Ensure ongoing compliance with FDA 21 CFR Part 820 and ISO 13485, maintaining the integrity and effectiveness of the DEKA QMS.
• Develop a strong working knowledge of DEKA’s QMS processes and use this expertise to identify and implement system improvements.
• Review and approve quality records, ensuring accuracy, completeness, and adherence to applicable requirements.
• Conduct internal audits and support auditor training efforts to promote audit readiness and compliance with regulatory requirements.
• Support external audits (e.g., FDA, ISO, customer audits) by preparing documentation, facilitating audit logistics, and responding to auditor requests in real time.