Sr. Validation Engineer
VB Spine, LLC
•$105,000 - $135,000
About The Position
We believe in growing talent from within. At VB Spine, join a high-performing Quality team where you’ll play a critical role in ensuring the validation integrity and compliance of systems that support the safety and performance of innovative spinal products.
Requirements
- 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
- 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
Nice To Haves
- 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
Responsibilities
- 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
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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What This Job Offers
Job Type
Full-time
Career Level
Senior
