Job Description

Sr. 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 Sr. 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

Job Tags

Worldwide,

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Sr. Staff NC/Capa Specialist Job at VB Spine, Allendale, NJ

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