Sr. Quality Engineer

VB Spine, LLC; Leesburg (VA); On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

PTO & holidays

Training opportunities

Career growth

Job summary

VB Spine is seeking a Senior Quality Engineer to support the CQR function in the Spine division. You’ll provide advanced quality assurance, control, and preventative expertise across manufacturing, supplier quality, and compliance to drive continuous improvement.

You will collaborate with Operations and cross‑functional teams to maintain high product and process quality, lead CAPAs and MRBs, and mentor teams on GMP and quality practices while supporting audits and change management.

Qualifications

• Bachelor’s degree in Engineering is required.
• Minimum 3+ years of quality engineering experience in the medical device industry or a regulated manufacturing environment.
• Strong knowledge of quality concepts and regulatory requirements (ISO 13485, FDA QSR, EU MDR).
• Experience interacting with regulatory agencies and supporting audits (FDA, Notified Bodies).
• 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) are desirable.

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 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).
• 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.

Skills

Quality concepts

Regulatory compliance

Root cause investigation

Problem solving

Cross-functional collaboration

Project management

GMP knowledge

CQE / Six Sigma (desirable)

Education

Bachelor’s degree in Engineering

Job description

Senior Quality Engineer

Location: Leesburg, VA

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 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. As a Senior Quality Engineer in our CQR function within the Spine division, you’ll provide advanced quality assurance, control, and preventative expertise — supporting manufacturing processes, supplier quality, and compliance while driving continuous improvement across product and process quality.

What You’ll Do

• 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

What You Bring

• 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

Why VB Spine

We believe in growing talent from within. At VB Spine, join a high‑performing team where you’ll play a critical role in ensuring the quality and safety of innovative spinal implants and instruments that improve patient lives.

Compensation

Pay for this role is competitive and based on experience, qualifications, and performance. 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.

Benefits include

• 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