Quality Engineer, Post Market

Quality Engineer

Location: Leesburg, VA (Hybrid)

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 Reliability / Quality Engineer who is passionate about driving product excellence, conducting thorough failure investigations, and ensuring regulatory compliance. This role offers the opportunity to collaborate cross-functionally, improve product reliability, and enhance patient safety in a dynamic, fast-paced environment.

What You'll Do:

• Improve product quality, reliability, and customer satisfaction by investigating field failures and conducting trend analysis

• Perform timely, accurate, and complete failure investigations and root cause analyses using tools such as RCA, 4D, and 5 Whys; document findings in TrackWise

• Lead cross-functional teams to identify issues and drive product improvements

• Apply design and manufacturing best practices to recommend preventive measures against future failures

• Support resolution of field issues in collaboration with R&D, Advanced Quality Engineering, and Operations

• Lead product family complaint reviews by presenting complaint trends and recommendations for corrective action

• Partner with Advanced Quality Engineers to complete Post-Market Health Risk Assessments

• Maintain awareness of U.S. and international regulations pertaining to medical devices

• Participate in internal and external audits

• Perform reliability analyses to identify and address negative trends

• Other duties as assigned

What You Bring:

• Bachelor's Degree in Engineering required

• 0-2 years of experience as a Reliability Engineer, Quality Engineer, or relevant role conducting failure investigations/failure analysis

• Applied knowledge of advanced reliability tools (FMEA, reliability testing, statistical techniques)

• Ability to work effectively cross-functionally with R&D, Regulatory Affairs, Sales, Marketing, and Operations

• Strong interpersonal and communication skills with a collaborative mindset

• Demonstrated ability to advocate for product excellence and quality

• Knowledge of FDA and international medical device regulations/standards (ISO 13485, ISO 14971, 21CFR820, 93/42/CE, cGMPs) preferred

• Physical ability to sit, walk, lift up to 20 lbs., with good eye-hand coordination

• Mental ability to read, complete simple math, and manage moderate levels of stress

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 improve the lives of patients through innovative spinal solutions. This role positions you to influence product quality, reliability, and innovation across the organization.

Compensation:

Pay for this role is competitive and based on experience, with additional factors like qualifications and performance taken into account. The typical pay range for this position is $80,000 - $100,000 annually, with a 7% annual bonus opportunity 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

• Hybrid work schedule in Leesburg, VA

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