Senior Quality EngineerLocation: Leesburg, VA
Company: VB Spine
What You'll Do:- Collaborate closely with Operations and cross-functional teams to ensure high quality performance of products and manufacturing processes
- Serve as the Quality representative on cross-functional teams to resolve key quality issues in new product development and sustaining activities
- Lead internal and supplier-driven non-conformances (NCs), CAPAs, and Material Review Board (MRB) dispositions with timely closure
- Conduct risk management activities and support change management for internal and supplier processes
- Perform supplier control activities including on-site and desktop audits, maintaining the Approved Supplier List (ASL), and supporting part approval processes
- Support and lead quality initiatives, internal/external audits, and inspection readiness activities
- Review, execute, and approve equipment, process, MSA, and software validation protocols and reports
- Monitor quality KPIs, analyze trends, and drive corrective actions to improve process and product quality
- Support product transfers, engineering changes, manufacturing-related complaints, and field actions
- Apply statistical tools and process control methods to support quality system processes and management reviews
- Collaborate with Regulatory on Instructions for Use (IFUs) and review/approve quality records
- Mentor and train functional groups on GMP, quality concepts, and best practices
- Work within the ERP system to support purchasing, manufacturing, and quality processes
What You Bring:- Bachelor's degree in Engineering required (Biomedical, Mechanical, Process, or related discipline preferred)
- Minimum 3+ years of experience in a quality engineering role within the medical device industry (or equivalent technical experience in a regulated manufacturing environment)
- Strong knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics) and regulatory requirements (ISO 13485, FDA QSR, EU MDR, etc.)
- Experience interacting with regulatory agencies and supporting audits (FDA, Notified Bodies, etc.)
- Proficiency in reading and interpreting engineering drawings and technical specifications
- Excellent problem-solving, analytical, technical writing, and root cause investigation skills
- Strong project management and cross-functional collaboration abilities
- Professional certifications (CQE, Six Sigma, Lead Auditor, etc.) are highly desirable
Compensation:Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $100,000.00 - $110,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including 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 opportunities
- Opportunity to grow within a fast-paced, dynamic company
