CAPA & Nonconformance Quality Engineer II

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

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.

• 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.

• 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.
• Track Wise experience preferred.

$71,300.00 - $97,750.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following company-sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards.

Integra Life Sciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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