Staff Quality Engineer

Staff 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 looking for a Staff Quality Engineer who can thrive in a fast-paced environment, lead complex quality initiatives, and support high-impact programs that drive product excellence and patient safety.

What You'll Do:

• Work closely with operations and business functions to ensure product and process quality performance

• Serve as the Quality representative on cross-functional teams to resolve key quality issues

• Lead quality initiatives that support compliance to standards and drive process improvements

• Develop, maintain, and improve internal procedures, SOPs, and work instructions

• Assess internal and supplier change management activities

• Apply risk management practices to manufacturing operations

• Lead internal and supplier non-conformances and ensure timely closure

• Lead CAPA projects, including investigation, implementation, and closure

• Act as SME during audits by regulatory agencies, notified bodies, and other authorities

• Lead process and quality system projects of moderate scope and complexity

• Disposition non-conforming product within the MRB

• Maintain KPIs, perform analyses, and interpret trends to drive action

• Identify and execute supplier part certification opportunities

• Support creation and maintenance of inspection methods and sampling plans

• Perform supplier control activities, including on-site and desktop audits

• Manage and maintain the Approved Supplier List (ASL)

• Lead development and improvement of manufacturing processes

• Lead supplier part approval activities for new products and changes

• Apply foundational knowledge of manufacturing processes (milling, turning, heat treatment, passivation/cleaning)

• Execute internal quality deliverables for engineering changes, product transfers, and supplier-initiated changes

• Lead complex product transfers between manufacturing sites

• Lead containment and communication activities related to potential product escapes

• Lead execution and analysis of manufacturing-related complaints and field actions

• Review, execute, and approve equipment, process, MSA, and software validation protocols/reports

• Collaborate with Regulatory on creation and revision of IFUs

• Review and approve quality records

• Utilize ERP systems for purchasing and manufacturing quality processes

• Promote Human Factors practices, including identification and mitigation strategies

• Apply statistical analysis and process control methods for CAPA, management review, and QMS processes

• Provide training (GMP, onboarding, etc.) and cross-functional support for NPD and process changes

• Provide subject matter expertise and mentorship to junior Quality team members

What You Bring:

• Bachelor's degree required; Engineering discipline preferred (Biomedical, Process, Mechanical)

• Minimum 5 years' experience in a quality role within a medical device company (or equivalent regulated manufacturing experience)

• Professional quality certification (MS, CQE, CRE, Six Sigma) highly desirable

• Knowledge of quality concepts (Risk Management, CAPA, Audits, Statistics)

• Knowledge of regulatory requirements (ISO 13485, FDA QSR, EU MDR)

• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.)

• Strong investigation and root-cause analysis skills preferred

• Process improvement and auditing skills preferred

• Ability to read engineering drawings/technical specifications preferred

• Ability to multitask, work independently, and participate in cross-functional teams

• Project management skills and ability to influence without authority

• Excellent communication, analytical, problem-solving, and technical writing skills

• High attention to detail and strong organizational skills

• Ability to meet physical requirements such as standing, walking, sitting, reaching, and standard vision capabilities

Why VB Spine?
We believe in growing talent from within. At VB Spine, you'll join a high-performing team, benefit from peer and executive mentorship, and help shape strategy in the dynamic field of medical devices—positioning yourself to influence growth and innovation across the organization.

Compensation:
Pay for this role is competitive and based on experience, with additional factors like territory requirements, qualifications, and performance taken into account. The typical pay range for this position is $105, ,000 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined case-by-case and considers 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

• Opportunity to grow within a fast-paced, dynamic company