Sr. Staff NC/Capa Specialist (Allendale)VB Spine • Allendale, NJ, United States
Sr. Staff NC / Capa Specialist (Allendale)
VB Spine • Allendale, NJ, United States
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job_description.job_card.job_descriptionBachelors degree in science, engineering, or related discipline (Masters, 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 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
Sr. Staff NC / CAPA Specialist
Location : Leesburg, VA
Company : VB Spine
Looking for a career where your work truly matters? At VB Spine, youll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. Were 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, youll serve as a subject matter expert, mentor teams in structured problem-solving, and drive compliance, effectiveness, and continuous improvement across the organization.
What Youll 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
Why VB Spine?
We believe in growing talent from within. At VB Spine, youll join a high-performing team, benefit from mentorship at all levels, and help shape quality strategy in the dynamic medical device industrypositioning 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
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Staff Specialist • Allendale, NJ, United States
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