Senior NC/CAPA Specialist

Senior NC/CAPA Specialist (Remote/Hybrid)

Memphis, TN

 
This role plays a critical part in protecting patients and advancing product quality by ensuring robust, effective corrective and preventive action processes. You will influence how quality decisions are made across the site and beyond, shaping behaviors, strengthening compliance, and enabling continuous improvement.

Work Flexibility

Remote or Hybrid options available

Remote: Highly preferred candidates located in the EST or CST time zones

Hybrid: Candidates must live within commuting distance of Memphis, TN and be available to work onsite several times per week

What You Will Do

• Ensure compliance with corrective and preventive action processes by reviewing and approving nonconformances and corrective action records for accuracy, completeness, effectiveness, and on‑time closure.
• Guide and mentor teams through all stages of corrective action management, ensuring required documentation and evidence are maintained as active records within the electronic system.
• Facilitate root cause analysis by leading workshops and coaching teams in structured problem-solving methods such as human error reduction, cause‑and‑effect analysis, and process mapping.
• Lead review forums by organizing and executing site and multi‑site corrective action review boards, including participation in global quality forums.
• Monitor performance by managing site corrective action metrics, preparing reports, and providing data‑driven updates for quality and business reviews.
• Act as a subject matter expert by interpreting and applying quality system procedures and regulatory requirements, and serving as system super‑user.
• Develop and deliver training to ensure consistent and compliant use of corrective action processes and systems across all user groups.
• Support audits and improvement initiatives by leading audit preparation and follow‑up activities and participating in cross‑site and corporate quality system improvement projects.

What You Will Need

Required Qualifications

• Bachelor’s degree in science, engineering, or a related discipline
• 2+ years of experience in a manufacturing environment
• 2+ years of experience in quality systems, quality engineering, or a related regulated function

Preferred Qualifications

• Experience interacting with regulatory or notified bodies (e.g., U.S. or international regulators)
• Experience applying U.S. and international medical device regulations and industry standards
• Prior experience supporting quality system audits or working in a compliance‑risk environment
• Experience working across multiple sites or within a matrixed or corporate quality structure

$72,500.00 - $157,200.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.