Medical Device Quality Investigations Lead (CAPA/NC)

REALIGN LLC; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

REALIGN LLC is seeking a quality investigations professional to lead CAPA and Nonconformance efforts within a medical device context. You will drive containment, data collection, root cause analysis, and corrective actions, while ensuring records are complete and traceable.

You will coordinate with process owners and subject-matter experts, maintain action timelines, and support regulatory or customer inspections. Strong documentation and office software skills are essential.

Qualifications

• Strong written and verbal communication skills for documenting and presenting investigation outcomes.
• Experience in the medical device industry is a plus.
• Working knowledge of CAPA and NC processes.
• Hands-on experience managing quality investigations including containment and corrective actions.
• Ability to develop objective, traceable, evidence-based investigation documentation.
• Strong organizational and follow-up skills for coordinating actions and timelines.
• Ability to prioritize multiple investigations while maintaining attention to detail.
• Experience using an eQMS; ETQ experience preferred.
• Proficiency with Word, Excel, PowerPoint, Outlook and Teams.

Responsibilities

• Execute and manage CAPA and Nonconformance investigations per procedures and quality-system requirements.
• Lead investigations from initiation to closure, including containment, data collection, root cause analysis, and corrective actions.
• Apply structured problem-solving methods to determine causes and support risk-based decisions.
• Coordinate with owners, SMEs, and cross-functional users to obtain evidence and complete actions.
• Facilitate follow-up meetings, document decisions, and communicate risks and delays.
• Ensure investigation records are accurate, timely, and well-supported.
• Track milestones and maintain visibility of open actions for timely closure.
• Enter and maintain quality records in the eQMS; ETQ experience preferred.
• Support quality metrics, audits, and inspections; identify opportunities to improve processes.

Skills

Communication skills

CAPA/NC knowledge

Investigation management

Root cause analysis

Documentation

Cross-functional coordination

Prioritization

eQMS experience

Office software

Tools

ETQ eQMS

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Microsoft Teams

Job description

REALIGN LLC is seeking a quality investigations professional to lead CAPA and Nonconformance efforts within a medical device context. You will drive containment, data collection, root cause analysis, and corrective actions, while ensuring records are complete and traceable.

You will coordinate with process owners and subject-matter experts, maintain action timelines, and support regulatory or customer inspections. Strong documentation and office software skills are essential.