Sr. Quality Engineer
VB Spine, LLC•Leesburg, VA
•$100,000 - $110,000
About The Position
VB Spine is seeking a Sr. Quality Engineer to join their high-performing team. This role is critical in ensuring the quality and safety of innovative spinal implants and instruments that improve patient lives. The position involves collaborating closely with Operations and cross-functional teams to maintain high quality performance of products and manufacturing processes, serving as the Quality representative in new product development and sustaining activities, and leading quality initiatives.
Requirements
- 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
Nice To Haves
- Professional certifications (CQE, Six Sigma, Lead Auditor, etc.) are highly desirable
Responsibilities
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
