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 - 135,000 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

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If you believe you belong to any of the categories of protected veterans listed below, please indicate by selecting the appropriate category(ies). The hiring employer is subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA) and requests this information in order to measure the effectiveness of the outreach and positive recruitment efforts it undertakes pursuant to VEVRAA.

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We are required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

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