CAPA 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.

Essential Duties and 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.

Desired Minimum Qualifications

• 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.
• TrackWise experience preferred.

Salary Pay Range:

$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. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

 

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, and 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 LifeSciences

Integra LifeSciences 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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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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