Quality Systems Engineer

JobDiva, Inc.; Irvine (CA); On-site; USD 95,000 - 135,000; Full time

Job summary

JobDiva, Inc. in Irvine, CA is seeking a Quality Systems Engineer to support quality-system activities in a regulated medical-device environment. You will manage CAPA, NC investigations, and documentation.

The role requires strong problem-solving, data collection, containment, root-cause analysis, and effective communication with stakeholders. Bachelor’s degree in Engineering or Life Sciences is required.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Hands-on experience with CAPA and Nonconformance (NC) processes.
• Experience in the medical device industry.
• Ability to develop objective, evidence-based investigation documentation.
• Strong written and verbal communication and organizational skills.

Responsibilities

• Execute and manage CAPA and Nonconformance investigations per procedures.
• Lead investigations from initiation through closure with containment, data collection and root-cause analysis.
• Prepare corrective actions and effectiveness planning.
• Maintain quality records in the eQMS and ensure documentation is inspection-ready.
• Coordinate with owners and stakeholders to obtain evidence and close actions.
• Communicate investigation status, risks, and escalation needs.

Skills

CAPA management

Nonconformance investigations

Root-cause analysis

Quality documentation

Data collection

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

eQMS software

Job description

Job Description:

• We are seeking a Quality Systems Engineer to support quality-system activities within a regulated medical-device environment. The ideal candidate will have hands‑on experience with CAPA, Nonconformance (NC) investigations, root‑cause analysis, corrective actions, and quality documentation.
• The candidate should be highly organized, detail-oriented, and capable of managing multiple investigations and quality‑system deliverables while collaborating effectively with cross‑functional stakeholders.

Responsibilities:

• Execute and manage CAPA and Nonconformance investigations in accordance with applicable procedures and quality‑system requirements.
• Lead investigations from initiation through closure, including:
• Immediate containment.
• Issue/problem definition and bounding.
• Data collection.
• Root‑cause analysis.
• Corrections.
• Corrective actions.
• Effectiveness planning, where applicable.
• Apply structured problem‑solving and root‑cause analysis methodologies to determine the causes of quality issues.
• Support risk‑based decision‑making and ensure appropriate documentation of investigation conclusions.
• Coordinate with investigation owners, process owners, subject‑matter experts, and cross‑functional stakeholders to obtain objective evidence and complete assigned actions.
• Facilitate investigation follow‑up meetings and document decisions, action items, risks, and escalations.
• Proactively communicate investigation status, delays, risks, and potential escalation requirements.
• Ensure investigation records are accurate, clear, complete, timely, traceable, and supported by appropriate evidence and rationale.
• Track CAPA, NC, and investigation milestones and maintain visibility of open actions through timely closure.
• Enter, update, route, and maintain quality records in the applicable electronic Quality Management System (eQMS).
• Support quality‑system activities and ensure documentation is inspection‑ready.
• Maintain strong follow‑up and coordination across multiple quality‑system activities.
• Ensure compliance with applicable company procedures and regulatory requirements.
• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline

Must-Have Technical / Functional Skills:

• Strong written and verbal communication skills with the ability to clearly document and present investigation outcomes.
• Previous experience in the medical device industry.
• Working knowledge of CAPA and Nonconformance (NC) processes.
• Hands‑on experience managing quality investigations, including:
• Containment
• Issue bounding
• Root‑cause analysis
• Corrections
• Corrective actions
• Ability to develop clear, objective, evidence‑based investigation documentation.
• Strong organizational and follow‑up skills.