Senior Quality Engineer - Medical Device, QA Lead & CAPA

VB Spine; Leesburg (VA); On-site; USD 95,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) match

PTO & holidays

Professional development

Job summary

VB Spine in Leesburg, VA seeks a Senior Quality Engineer to lead quality assurance, control, and supplier quality for medical devices, covering process development, verification, validation, and product transfer in a regulated environment.

You will collaborate with Operations to ensure product quality, manage CAPA and NCs, support audits, and drive improvements, with 25% travel to Allendale, NJ. Requires a Bachelor's in Engineering and 3+ years of medical device quality experience.

Qualifications

• Bachelor’s degree in Engineering.
• Minimum 3 years of quality experience in medical devices or regulated manufacturing.
• Strong knowledge of quality concepts and statistics.
• Familiar with ISO 13485, FDA QSR, EU MDR (desired).
• Experience interacting with regulatory agencies preferred.

Responsibilities

• Collaborate with Operations to ensure quality performance of products and processes.
• Serve as the Quality representative on cross-functional teams to address key quality issues.
• Execute quality initiatives that support compliance and drive process improvements.
• Support the development, maintenance, and continuous improvement of internal procedures, SOPs, and work instructions.
• Critically assess internal and supplier change management activities.
• Lead internal and supplier-driven non-conformances (NCs) and CAPA projects with timely root cause investigation and closure.
• Serve as a subject matter expert for internal and external audits, managing both front-room and back-room logistics.
• Disposition non-conforming product within the MRB.
• Maintain and analyze quality KPIs to drive appropriate actions.
• Perform supplier control activities including audits, supplier file management, and maintenance of the ASL.
• Lead part approval activities and support process development/improvement with suppliers.
• Support product transfers, engineering changes, manufacturing-related complaints, and field actions.
• Review, execute, and approve equipment, process, MSA, and software validation protocols and reports.
• Collaborate with Regulatory on IFUs and review/approve quality records.
• Apply statistical analysis and process control methods to support quality system processes.
• Train functional groups on GMP and quality best practices as needed.

Education

Bachelor's degree in Engineering

Biomedical/Process/Mechanical Engineering preferred

Job description

VB Spine in Leesburg, VA seeks a Senior Quality Engineer to lead quality assurance, control, and supplier quality for medical devices, covering process development, verification, validation, and product transfer in a regulated environment.

You will collaborate with Operations to ensure product quality, manage CAPA and NCs, support audits, and drive improvements, with 25% travel to Allendale, NJ. Requires a Bachelor's in Engineering and 3+ years of medical device quality experience.