Senior Quality Engineer – Medical Devices, CAPA & Audits

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

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.