Distribution Quality Lead in Warsaw at VB Spine

Distribution Quality Lead

Location: Poland
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 looking for driven individuals ready to learn quickly, adapt under pressure, and grow in a dynamic, fast-paced environment.

As Distribution Quality Lead, you will be responsible for quality leadership at the Regional Distribution Centre, ensuring compliance with corporate quality systems, global regulatory requirements and applicable GxP standards.

This involves close collaboration with the VB Spine Corporate Quality Team, cross-functional stakeholders and international authorities, in order to maintain effective quality oversight and support compliant distribution operations.

Key elements of the site quality management system will be overseen, including complaints, nonconformances, CAPAs, holds, deviations, change control, audits and GxP documentation. You will also ensure appropriate oversight of distribution and storage activities, product traceability, supplier quality, validation and maintenance programmes, while driving quality reporting, risk escalation, training compliance and continuous improvement across the site.

What You’ll Do:

• Lead regional quality operations, partnering with Corporate Quality, cross‑functional teams, and international authorities.
• Oversee complaint handling, Post‑Market Surveillance, NC/CAPA processes, deviations, and quality event investigations.
• Manage change control, GxP documentation, MasterControl procedures, and alignment with global quality standards.
• Ensure distribution‑site quality oversight, including storage, traceability, lot control, product holds, and recalls.
• Serve as the primary lead for audits, internal auditing, and interactions with Notified Bodies and Health Authorities.
• Oversee supplier management, training and capability of GxP teams, and execution of validation protocols.
• Drive process improvements, preventative maintenance, calibration programs, and continuous quality enhancement.

What you bring:

• A university degree (Bachelor’s in Science or equivalent required).
• At least 5 years of experience in quality or a related field.
• Hands‑on experience with electronic NC/CAPA systems (e.g., TrackWise Digital) and familiarity with ERP platforms such as JDE; strong understanding of quality concepts, including risk management, CAPA, audits, and basic statistics.
• Solid knowledge of applicable regulatory requirements (ISO 13485, FDA QSR, EU MDR) and working knowledge of GMP for medical devices.
• Strong written and verbal communication skills, with the ability to clearly convey procedures, inspection requirements, KPIs, and quality expectations across all organisational levels.
• Proficiency in Microsoft Office, ERP systems, document‑control tools, and statistical software (Minitab preferred), with the ability to analyse and present data effectively.
• Excellent organisational and time‑management skills, with a detail‑oriented approach and the ability to manage multiple priorities while maintaining high-quality standards.

About VB Spine:

VB Spine, LLC is the largest privately held spine company and among the largest family-owned medical technology companies in the world. Our globally recognised identity as innovators and stewards of the spine industry reflects our commitment to patient outcomes first. With a comprehensive product portfolio and a large and growing global distribution network, VB Spine delivers specialised solutions that address critical needs in spine surgery and enhance patient outcomes. VB Spine is a strategic partner to Stryker with access to Mako Spine and Copilot.

Focused on people, partnerships and operational excellence, VB Spine ensures healthcare professionals have access to the tools and resources needed to provide the highest standard of care.

Compensation:

Pay for this role is competitive and based on experience, with qualifications and performance taken into account.

This role is with a hybrid work model. While non-local candidates may apply, relocation and housing assistance are not provided, and candidates are responsible for all related expenses.

Final compensation is determined on a case-by-case basis and considers factors such as experience level, skill set, and market conditions.