Sr. Quality Engineer

VB Spine, LLC; Allendale (NJ); On-site; USD 100,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off

Ongoing training and development

Growth opportunities

Job summary

VB Spine, LLC is seeking a Quality professional in New Jersey to lead quality initiatives across the organization. The role focuses on risk management, CAPA and supplier quality, with responsibility for audits and continuous improvement of procedures and workflows.

You will collaborate with Operations and cross-functional teams to ensure products meet quality requirements, and you will drive process improvements and change management activities in a regulated medical device environment.

Qualifications

• Knowledge of Quality concepts including CAPA, audits, risk management, and statistics.
• Familiarity with ISO 13485, FDA QSR, EU MDR is preferred.
• Experience with regulatory interactions and quality system processes.
• Ability to read and interpret engineering drawings and specifications.
• Formal investigation and root-cause analysis skills are desirable.

Responsibilities

• Collaborate with Operations and cross-functional teams to ensure product and process quality.
• Act as Quality representative on cross-functional teams addressing key issues.
• Lead risk management activities including risk plans, reviews and controls.
• Manage NCs and CAPA projects with root-cause investigation and closure.
• Lead internal and supplier audits and manage MRB activities.
• Dispost non-conforming product within MRB and maintain quality KPIs.
• Oversee supplier control, ASL maintenance, and supplier audits.
• Support product transfers, engineering changes, and field actions.
• Review validation protocols and reports for equipment, processes, MSA, and software.
• Collaborate with Regulatory on IFUs and quality records.
• Provide GMP training to functional groups as needed.

Skills

Quality concepts

Risk management

CAPA

Audits

Statistics

Regulatory knowledge

Reading drawings

Education

Bachelor's degree in Engineering

Job description

What You’ll Do:

• Collaborate closely with Operations and cross-functional teams 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 risk management activities, including developing risk plans/reports, conducting risk reviews, and verifying risk controls
• 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 Material Review Board (MRB)
• Maintain and analyze quality KPIs to drive appropriate actions
• Perform supplier control activities including audits, supplier file management, and maintenance of the Approved Supplier List (ASL)
• Lead part approval activities and support process development/improvement efforts 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 Instructions for Use (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

What You Bring:

• Bachelor’s degree required (Engineering discipline preferred — Biomedical, Process, or Mechanical Engineering recommended)
• Minimum of 3 years of experience in a quality role within a medical device company (or equivalent technical experience in a regulated manufacturing environment)
• Strong knowledge of Quality concepts (Risk Management, CAPA, Audits, Statistics)
• Knowledge of applicable regulatory requirements (ISO 13485, FDA QSR, EU MDR, etc.) desired
• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred
• Professional certifications (CQE, Six Sigma, Lead Auditor, etc.) highly desirable
• Formal investigation, root cause analysis, process improvement, and process-based auditing skills preferred
• Ability to read and interpret engineering drawings and technical specifications preferred
• Strong project management skills and the ability to influence without authority

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high-performing Quality team where you’ll play a critical role in ensuring the safety, compliance, and continuous improvement of innovative spinal products that improve patient lives.

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