Quality Engineer
Description:
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 seeking a Quality Engineer to provide support and direction in quality assurance, control, and preventive activities. In this role, you'll manage quality initiatives for internal and external suppliers related to process development, verification, validation, and product transfer-ensuring compliance with regulations and standards while driving improvements across operations.
What You'll Do:
Work closely with Operations and business functions to ensure quality performance of products and processes.
Serve as the Quality representative, collaborating with cross-functional teams to resolve quality issues.
Execute quality initiatives to support compliance with standards and identify process improvement opportunities.
Support the development, maintenance, and improvement of procedures, SOPs, and work instructions in alignment with evolving standards and regulations.
Lead investigations of internal and supplier non-conformances, CAPA projects, and ensure timely root cause analysis and closure.
Support and participate in internal/external audits by regulatory agencies and notified bodies.
Disposition non-conforming product within the Material Review Board (MRB).
Maintain KPIs for monitoring product and process quality, analyze trends, and drive corrective actions.
Support supplier quality activities including audits, supplier approval, inspection methods, and ongoing monitoring.
Collaborate with suppliers and stakeholders on part approvals, process development, and certification activities.
Review, execute, and approve validation protocols and reports (equipment, process, software, and MSA).
Execute quality deliverables related to engineering changes, product transfers, and supplier-initiated changes.
Support complaint investigations, field actions, and product holds as required.
Train cross-functional teams in GMP, quality practices, and onboarding where needed.
What You Bring:
Bachelor's degree required; Engineering discipline preferred (Biomedical, Process, or Mechanical Engineering recommended).
Experience in a quality role within medical devices or other regulated manufacturing environments (entry-level candidates considered with equivalent technical background).
Knowledge of quality concepts including risk management, CAPA, audits, and statistics.
Ability to read and interpret engineering drawings and technical specifications.
Strong problem-solving, analytical, and technical writing skills.
Excellent communication and interpersonal skills.
High level of attention to detail, organization, and ability to manage multiple priorities.
Physical & Mental Requirements:
Regularly required to use hands for handling, tools, and controls.
Frequently required to stand, walk, sit, reach, and communicate.
Specific vision abilities include close, distance, color, peripheral vision, depth perception, and focus adjustment.
Ability to lift/move up to 25 pounds occasionally.
May require PPE for exposure to certain environments.
Why VB Spine?
We believe in growing talent from within. At VB Spine, you'll join a high-performing team, benefit from mentorship, and contribute to advancing spinal solutions in a dynamic, fast-paced environment. You'll have the opportunity to directly influence product quality and patient outcomes.
Compensation:
Pay for this role is competitive and based on experience. The typical pay range for this position is $85,000 - $100,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers experience, 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