About this opportunity
VB Spine, LLC lists this Quality Engineer, Post Market opportunity in leesburg, Virginia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Quality Engineer, Post Market
VB Spine Leesburg, Virginia, United States
About this position
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.
Location: Leesburg, VA (Less than 10% Travel Required)
Company: VB Spine
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
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Worksite address
leesburg, VA, 22075, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.