VB Spine, LLC is a global patient-focused and innovation-driven spine company formed after the acquisition of Stryker’s U.S. spine implant business by the Viscogliosi Brothers. 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.
Senior Validation Engineer
Location
United States
Posted
5 days ago
Salary
$105K - $135K / year
Seniority
Senior
No structured requirement data.
Job Description
Senior Validation Engineer
VB Spine, LLC
Role Description - Develop, review, execute, and maintain validation protocols, reports, and documentation for equipment, manufacturing processes, measurement systems (MSA), and software to support new product introductions, process improvements, and sustaining activities. - Conduct periodic reviews of validated systems, equipment, processes, and software to ensure ongoing compliance and alignment with regulatory requirements and internal procedures. - Serve as the subject matter expert for validation and inspection processes, ensuring compliant implementation across internal teams and external suppliers. - Apply statistical analysis and process control methods to support management reviews, CAPAs, and quality system processes. - Lead quality system projects of moderate scope and complexity. - Collaborate closely with Operations and other business functions to ensure quality performance of products and processes. - Support the creation and maintenance of inspection methods, sampling plans, and first article inspections. - Apply foundational knowledge of manufacturing processes (milling, turning, heat treatment, passivation/cleaning) and their impact on product quality. - Execute quality deliverables related to engineering changes, product transfers, and supplier-initiated changes. - Lead the development, maintenance, and continuous improvement of internal procedures, SOPs, and work instructions. - Lead internal and supplier-driven non-conformances and manage timely closure of NCs. Qualifications - Bachelor’s degree required (Engineering discipline preferred). - Minimum of 5 years of experience in a quality role within a medical device company (or equivalent technical experience in a regulated manufacturing environment). - Strong knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics). - Knowledge of applicable regulatory requirements (ISO 13485, FDA Quality System Regulation, EU MDR, etc.) required. - Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred. - Professional certifications (CQE, CRE, Six Sigma, etc.) highly desirable. - Formal investigation, root cause analysis, and process improvement skills preferred. - Ability to read and interpret engineering drawings and technical specifications preferred. - Strong project management skills and the ability to influence without authority. - Excellent verbal, written, and interpersonal communication skills. - High attention to detail, strong analytical and technical writing skills, and the ability to multi-task independently. Benefits - 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, dynamic company.
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