Quality Engineer, Post Market

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 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

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