Senior Quality Engineer – Medical Devices (CAPA & Audits)

Fleet Glass Services, Inc.; New Jersey; 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 in Leesburg, VA or Allendale, NJ seeks a Sr. Quality Engineer to lead quality assurance, control, and CAPA activities for medical device products. You will partner with Operations and suppliers to ensure compliant processes and successful product transfers.

The role requires a Bachelor's in engineering and at least 3 years of regulated manufacturing quality experience; ISO 13485, FDA QSR, and EU MDR knowledge is preferred. Competitive benefits and growth opportunities available.

Qualifications

• Bachelor's degree in engineering or related field.
• Minimum 3 years of quality experience in medical devices or regulated manufacturing.
• Knowledge of ISO 13485, FDA QSR, EU MDR preferred.
• Experience with CAPA, audits, and statistics.
• Ability to read engineering drawings and technical specifications.
• Strong cross-functional collaboration and project management skills.

Responsibilities

• Collaborate with Operations and cross-functional teams to ensure product quality.
• Serve as Quality representative on cross-functional teams addressing quality issues.
• Execute quality initiatives to support compliance and drive process improvements.
• Support development, maintenance, and improvement of internal procedures and SOPs.
• Lead internal and supplier-driven non-conformances (NCs) and CAPA projects.

Skills

Quality concepts

CAPA

Audits

Statistics

Regulatory interaction

Root cause analysis

Process improvement

Project management

GMP awareness

Documentation

Education

Bachelor's degree in engineering

Job description

VB Spine in Leesburg, VA or Allendale, NJ seeks a Sr. Quality Engineer to lead quality assurance, control, and CAPA activities for medical device products. You will partner with Operations and suppliers to ensure compliant processes and successful product transfers.

The role requires a Bachelor's in engineering and at least 3 years of regulated manufacturing quality experience; ISO 13485, FDA QSR, and EU MDR knowledge is preferred. Competitive benefits and growth opportunities available.