Sr. Quality Engineer

About the role

At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care.

Responsibilities

• Collaborate closely with Operations and cross-functional teams to ensure high quality performance of products and manufacturing processes
• Serve as the Quality representative on cross-functional teams to resolve key quality issues in new product development and sustaining activities
• Lead internal and supplier-driven non-conformances (NCs), CAPAs, and Material Review Board (MRB) dispositions with timely closure
• Conduct risk management activities and support change management for internal and supplier processes
• Perform supplier control activities including on-site and desktop audits, maintaining the Approved Supplier List (ASL), and supporting part approval processes
• Support and lead quality initiatives, internal/external audits, and inspection readiness activities
• Review, execute, and approve equipment, process, MSA, and software validation protocols and reports
• Monitor quality KPIs, analyze trends, and drive corrective actions to improve process and product quality
• Support product transfers, engineering changes, manufacturing-related complaints, and field actions
• Apply statistical tools and process control methods to support quality system processes and management reviews
• Collaborate with Regulatory on Instructions for Use (IFUs) and review/approve quality records
• Mentor and train functional groups on GMP, quality concepts, and best practices
• Work within the ERP system to support purchasing, manufacturing, and quality processes

Requirements

• Bachelor’s degree in Engineering required (Biomedical, Mechanical, Process, or related discipline preferred)
• Minimum 3+ years of experience in a quality engineering role within the medical device industry (or equivalent technical experience in a regulated manufacturing environment)
• Strong knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics) and regulatory requirements (ISO 13485, FDA QSR, EU MDR, etc.)
• Experience interacting with regulatory agencies and supporting audits (FDA, Notified Bodies, etc.)
• Proficiency in reading and interpreting engineering drawings and technical specifications
• Excellent problem-solving, analytical, technical writing, and root cause investigation skills
• Strong project management and cross-functional collaboration abilities
• Professional certifications (CQE, Six Sigma, Lead Auditor, etc.) are highly desirable

Qualifications

• Minimum 3+ years of experience in a quality engineering role within the medical device industry (or equivalent technical experience in a regulated manufacturing environment)
• Strong knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics) and regulatory requirements (ISO 13485, FDA QSR, EU MDR, etc.)
• Experience interacting with regulatory agencies and supporting audits (FDA, Notified Bodies, etc.)
• Proficiency in reading and interpreting engineering drawings and technical specifications
• Excellent problem-solving, analytical, technical writing, and root cause investigation skills
• Strong project management and cross-functional collaboration abilities
• Professional certifications (CQE, Six Sigma, Lead Auditor, etc.) are highly desirable

Skills

• Statistical tools and process control methods
• Collaboration with Regulatory on Instructions for Use (IFUs)
• Mentoring and training functional groups on GMP, quality concepts, and best practices
• ERP system support for purchasing, manufacturing, and quality processes

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

Pay

The typical pay range for this position is $100,000.00 - $110,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, skillset, and market conditions.

Schedule

Flexible schedule to accommodate the needs of the role and the company.

1817-Quality Leesburg, VA