Sr. CAPA Engineer

About the role

The Sr CAPA Quality Engineer plays a crucial role in supporting Integra's corporate CAPA program. This individual facilitates the tracking and closure of CAPAs and NCs, conducts root cause analyses, and develops and verifies action plans. They also coordinate with cross-functional teams and contribute to process improvements and training initiatives.

Responsibilities

• Facilitate the tracking and closure of Corporate CAPAs addressing company-wide Corrective and Preventive actions.
• Support CAPA owners in identifying issues, conducting root cause analysis, developing action plans, and verifying effectiveness.
• Coordinate across CAPA/NC teams to ensure consistent and compliant documentation.
• Facilitate the tracking and closure of corporate Nonconformances (NCs).
• Establish and maintain effective working relationships with QA, RA, and Operations Team members worldwide.
• Primarily hands-on worker, with instruction or supervision of others secondary to own technical work.
• Manage and/or coordinate programs within the function to achieve department goals and operating plans.
• Support the development and rollout of standardized QMS data sources and metrics across all levels of the organization.
• Facilitate quality metrics gathering, analyzing, and reporting on a regular and ad hoc basis.
• Maintain current knowledge of FDA and international Quality System regulations for medical devices and human tissue products.

Requirements

The ideal candidate holds a Bachelor's degree or equivalent with 8+ years of experience, or a Master's degree with 5+ years of experience, or a Doctoral degree with 3+ years of experience. Computer skills, including proficiency in Microsoft Office, Teams, Sharepoint, and knowledge of root cause analysis and problem-solving methodologies, are essential. Strong analytical and organizational skills, along with excellent written and oral communication abilities, are also required.

Qualifications

A recognized leader within the team, the individual manages and coordinates programs within the function to achieve department goals and operating plans. They support the development and rollout of standardized QMS data sources and metrics across all levels of the organization.

Skills

Strong analytical and organizational skills, excellent written and oral communication skills, critical and logical documentation review abilities, and proficiency in root cause analysis and problem-solving methodologies are necessary.

Benefits

Our benefits package includes medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, as well as a savings plan (401(k)).

Pay

The salary range for this position is $81,650.00 - $112,700.00 USD. Salary 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.