Sr. Staff NC/Capa Specialist

Senior Staff NC/CAPA Specialist

Location: Leesburg, VA

Company: VB Spine

Looking for a career where your work truly matters? At VB Spine, you'll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We're seeking a detail-oriented and experienced Senior Staff NC/CAPA Specialist to oversee our NC/CAPA process, ensuring the highest standards of product and process quality. In this role, you'll serve as a subject matter expert, mentor teams in structured problem-solving, and drive compliance, effectiveness, and continuous improvement across the organization.

What You'll Do:

• Oversee NC/CAPA processes, ensuring compliance with procedures and regulations

• Review and approve NCs and CAPAs for accuracy, completeness, and effectiveness

• Mentor and guide teams through all stages of NC/CAPA, fostering problem-solving excellence

• Serve as eCAPA (Trackwise Digital) super-user and subject matter expert

• Lead NC/CAPA review boards, including multi-site and global forums

• Monitor KPIs, generate reports, and ensure compliance with global quality metrics

• Facilitate root cause analysis workshops and drive accountability in CAPA ownership

• Provide training on NC/CAPA processes and systems across the organization

• Support audits, inspections, and product hold processes

• Identify and drive continuous improvement initiatives in quality systems

What You Bring:

• Bachelor's degree in science, engineering, or related discipline (Master's, CQE, or CRE preferred)

• Minimum of 6 years' experience in the medical device or other regulated industry

• Demonstrated expertise leading NC/CAPA processes

• Direct experience with FDA and Notified Body interactions

• Strong knowledge of US, EU, and international medical device regulations

• Applied experience with quality tools such as FMEA, GD&T, root cause analysis, and mistake-proofing/poka yoke

• Six Sigma Green or Black Belt certification preferred

• Familiarity with product development lifecycle, risk management, and design/process validation

• Strong project management, analytical, and problem-solving skills

• Excellent communication, facilitation, and cross-functional collaboration abilities

• Proficiency in Minitab or similar analysis software; Trackwise Digital experience preferred

• Confident in presenting to large groups

Why VB Spine?

We believe in growing talent from within. At VB Spine, you'll join a high-performing team, benefit from mentorship at all levels, and help shape quality strategy in the dynamic medical device industry-positioning yourself to influence innovation and patient outcomes worldwide.

Compensation:

Pay for this role is competitive and based on experience, with additional factors like qualifications and performance taken into account. The typical pay range for this position is $140,000 - $155,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers experience level, skillset, and market conditions.

Benefits include:

• Comprehensive health, dental, and vision insurance

• 401(k) with company match

• Paid time off (PTO) and holidays

• Ongoing training and professional development opportunities

• Opportunity to grow within a fast-paced, mission-driven company