Quality Engineer, Post Market

VB Spine, LLC; Leesburg (VA); On-site; USD 80,000 - 88,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

PTO and holidays

Ongoing training and development

Job summary

VB Spine is seeking a Quality Engineer, Post Market in Leesburg, VA to manage the end-to-end complaint handling process for medical devices, from intake to investigation and reporting. You will collaborate with the field, R&D, and cross‑functional teams to translate post‑market data into corrective actions.

The role requires a bachelor’s in a technical field and 0–1 year of quality experience in medical devices, with strong analytical, communication, and leadership potential for mentoring junior

Qualifications

• Bachelor’s degree in science, engineering, or related technical field.
• 0–1 years of quality experience in medical devices or equivalent.
• Knowledge of Quality concepts (e.g., CAPA, Audits, Risk Management).
• Strong communication and cross‑functional collaboration skills.

Responsibilities

• Support complaint intake, triage, and classification per SOPs and regulatory requirements.
• Lead and document root cause investigations for complaints and adverse events.
• Engage with surgeons, sales, and field partners to gather context and support timely root cause findings.
• Prepare adverse event reports and participate in PSURs and other regional reports.
• Perform trending analyses to identify signals and drive corrective actions.
• Contribute to PMHRA, PFAA, PHP and other internal surveillance activities.

Skills

Quality Assurance

Post-market surveillance

Root cause analysis

Regulatory knowledge

Power BI

Communication

Team mentorship

Education

Bachelor’s degree in science or engineering

Tools

Power BI

Basic coding

Automation

Job description

Quality Engineer, Post Market

Location: Leesburg, VA (Less than 10% Travel Required)

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 Quality Engineer, Post Market in our Quality Assurance function within the Spine division, you’ll support the end-to-end complaint handling process for medical devices — from intake and triage through root cause investigation, adverse event reporting, trending analysis, and summary reporting — partnering closely with the field, R&D, and cross-functional teams to turn post‑market intelligence into meaningful action.

What You’ll Do:

• Support complaint intake, triage, and classification in accordance with internal SOPs and applicable regulatory requirements
• Lead and document root cause investigations for reported complaints and adverse events, applying appropriate investigative methodologies
• Engage directly with surgeons, sales teams, and other field partners to gather clinical context, clarify product performance, and support timely root cause determination
• Determine reportability and prepare timely adverse event submissions to applicable competent authorities, including MDRs, MIRs, and equivalent global vigilance reports
• Author, contribute to, and review periodic post‑market surveillance reports, including PSURs, Canadian Summary Reports, and other regional reporting requirements
• Perform trending analysis on complaint and adverse event data to identify emerging product performance signals and elevate findings as appropriate
• Support data requests related to Post-Market Health Risk Assessments (PMHRA), Product Field Action Assessments (PFAA), Product Historical Performance reports (PHP), country‑specific requests, and other internal needs
• Support internal and external audits and inspections by providing documentation, data, and subject matter expertise related to post‑market surveillance activities
• Maintain accurate and complete documentation within the complaint handling and quality management systems, ensuring traceability, and audit readiness
• Provide mentoring and leadership to junior engineers
• Contribute to the development of new and improved quality processes and support process improvement initiatives that enhance the efficiency, consistency, and compliance of post‑market surveillance activities

What You Bring:

• Bachelor’s degree in science, engineering, or a related technical field required
• 0–1 years of experience in a quality role within a medical device company
• Knowledge of Quality concepts (e.g., Risk Management, CAPA, Audits, Statistics)
• Strong interpersonal, written, oral communication, and negotiation skills
• Strong critical thinking, “outside the box” thinking, and highly developed problem-solving and analytical skills
• Demonstrated ability to work independently and participate effectively in cross‑functional teams
• Computer literacy, including proficiency with Power BI, basic coding, or automations preferred
• Ability to read and interpret engineering drawings and other technical specifications preferred

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high‑performing Quality team where your work in post‑market surveillance will directly support product safety, regulatory compliance, and continuous improvement of innovative spinal devices 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 $80,000.00 - $88,000.00 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