CAPA Engineer II

Integra LifeSciences•Princeton, FL

About The Position

The CAPA Engineer II is responsible for supporting Corporate CAPAs, Nonconformances, and quality metrics in support of Integra’s corporate CAPA program. This individual works with CAPA and NC owners to support issue evaluation, root cause investigations, action plan development, implementation tracking, and verification of effectiveness activities. This role requires strong documentation, analytical, organizational, and communication skills, with the ability to work cross-functionally with Quality, Regulatory Affairs, Operations, and other business partners. The CAPA Engineer II is expected to manage assigned activities with moderate independence while escalating risks, delays, and quality concerns to the Sr. Manager, CAPA, NC and Metrics.

Requirements

Bachelor’s degree or equivalent with 5+ years of relevant experience, or Master’s degree with 3+ years of relevant experience.
Experience in Quality Assurance, CAPA, Nonconformance, Quality Systems, or related medical device / regulated industry function.
Experience with root cause analysis and problem-solving methodologies.
Strong analytical, organizational, and follow-up skills.
Ability to critically and logically review quality documentation.
Excellent written and oral communication skills.
Ability to work cross-functionally and maintain effective working relationships.
Computer skills including Microsoft Office, Teams, SharePoint, and online regulatory/compliance resources.

Nice To Haves

TrackWise experience preferred.

Responsibilities

Support tracking and closure of Corporate CAPAs addressing company-wide corrective and preventive actions.
Work with CAPA owners to support issue identification, investigations, root cause analysis, action plan development, action completion, and verification of effectiveness.
Support tracking and closure of Corporate Nonconformances to ensure consistency in evaluation, risk assessment, corrections, timeliness, quality, and documentation.
Coordinate with cross-functional CAPA and NC teams to ensure appropriate documentation of CAPA and NC activities.
Review CAPA and NC documentation for clarity, completeness, logical flow, procedural alignment, and compliance expectations.
Support quality metrics gathering, analysis, and reporting on a routine and ad hoc basis.
Assist with development and rollout of standardized QMS data sources and metrics across site, division, and corporate levels.
Escalate overdue items, documentation gaps, execution risks, and potential compliance concerns to management.
Support process improvements, training, and standardization activities related to CAPA, NC, and quality metrics.
Maintain current knowledge of FDA and applicable international Quality System regulations for medical devices and human tissue products.