Quality Engineer, Post Market
VB Spine, LLC•Leesburg, VA
•$80,000 - $88,000
About The Position
VB Spine is seeking a Quality Engineer for their Post-Market team. This role is crucial for ensuring product safety, regulatory compliance, and continuous improvement of innovative spinal devices. The engineer will support post-market surveillance activities, including complaint intake, root cause investigations, and regulatory reporting. This is an opportunity to grow talent within a high-performing Quality team and directly impact patient lives.
Requirements
- 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
Nice To Haves
- Computer literacy, including proficiency with Power BI, basic coding, or automations preferred
- Ability to read and interpret engineering drawings and other technical specifications preferred
Responsibilities
- 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 escalate 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
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
Entry Level
