VB Spine LLC
Senior Quality Engineer
Location : Leesburg, VA (hybrid) 25% travel
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 detail-oriented, driven Senior Quality Engineer to provide leadership in quality assurance, control, and preventive activities. In this role, you'll manage quality activities for internal and external suppliers, support process development, verification, validation, and product transfer, and ensure compliance with medical device regulations and industry standards.
What You'll Do:
We believe in growing talent from within. At VB Spine, you'll join a high-performing team, benefit from mentorship at all levels, and play a key role in advancing innovation in spinal care. Your work will have a direct impact on patient safety and surgical success.
Compensation:
Pay for this role is competitive and based on experience. Final compensation is determined on a case-by-case basis, considering skills, experience, and market conditions.
Benefits include:
Location : Leesburg, VA (hybrid) 25% travel
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 detail-oriented, driven Senior Quality Engineer to provide leadership in quality assurance, control, and preventive activities. In this role, you'll manage quality activities for internal and external suppliers, support process development, verification, validation, and product transfer, and ensure compliance with medical device regulations and industry standards.
What You'll Do:
- Partner with Operations and other business functions to ensure quality performance of products and processes.
- Serve as the Quality representative on cross-functional teams to address key quality issues.
- Support compliance to evolving standards and regulatory changes through the development and improvement of SOPs, work instructions, and procedures.
- Evaluate and manage internal and supplier change management activities.
- Apply risk management principles to manufacturing operations.
- Lead internal and supplier-driven non-conformances, CAPA investigations, and timely closures.
- Act as subject matter expert during internal and external audits, including front and backroom support.
- Disposition non-conforming product within the Material Review Board (MRB).
- Monitor and analyze KPIs to drive corrective actions and quality improvements.
- Collaborate with stakeholders to certify supplier parts and develop inspection methods.
- Conduct supplier control activities including audits, supplier file maintenance, and Approved Supplier List (ASL) updates.
- Support manufacturing process development and improvement efforts.
- Lead part approval activities for new products and changes.
- Execute quality deliverables for engineering changes, product transfers, and supplier-initiated changes.
- Lead containment activities for potential product escapes.
- Support manufacturing-related complaints and product field actions.
- Review, execute, and approve validation protocols and reports for equipment, processes, MSA, and software.
- Collaborate with Regulatory to develop and revise Instructions for Use (IFUs).
- Review and approve quality records.
- Apply statistical analysis and process control methods to support CAPAs and management reviews.
- Provide GMP training, onboarding, and other quality-related training as needed.
- Support new product development and changes to existing products and processes.
- Bachelor's degree required; Engineering discipline preferred (Biomedical, Process, or Mechanical Engineering recommended).
- Minimum 3 years' experience in a quality role within a medical device company (or equivalent regulated manufacturing experience).
- Professional certification in a quality discipline (e.g., Lead Auditor, CQE, CRE, Six Sigma) highly desirable.
- Knowledge of quality concepts such as Risk Management, CAPA, Audits, and Statistics.
- Understanding of applicable regulations (ISO 13485, FDA QSR, EU MDR) desired.
- Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Skills in formal investigation, root cause analysis, and process improvement preferred.
- Process-based auditing experience preferred.
- Ability to interpret engineering drawings and technical specifications.
- Strong project management skills and the ability to influence without authority.
We believe in growing talent from within. At VB Spine, you'll join a high-performing team, benefit from mentorship at all levels, and play a key role in advancing innovation in spinal care. Your work will have a direct impact on patient safety and surgical success.
Compensation:
Pay for this role is competitive and based on experience. Final compensation is determined on a case-by-case basis, considering skills, experience, 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
- Opportunities to grow within a fast-paced, dynamic company