Sr. Quality Engineer

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

Benefits offered by this job

Health insurance

401(k) with company match

PTO & holidays

Training & development

Career growth

Job summary

VB Spine, LLC in Leesburg, FL seeks a Quality Engineer to lead quality activities across product development and manufacturing. You will drive CAPAs, audits, supplier quality, and process validation while collaborating with regulatory affairs and manufacturing teams.

The role requires a bachelor's in engineering and 3+ years in a regulated quality environment, with strong problem-solving, RCA, and writing skills. On-site opportunity with competitive compensation.

Qualifications

• Bachelor’s degree in Engineering is required.
• Minimum 3+ years of experience in a quality engineering role in medical devices or regulated manufacturing.
• Strong knowledge of quality concepts, risk management, CAPA, audits, and statistics.
• Experience with regulatory agencies and audits (FDA, Notified Bodies).
• Ability to read engineering drawings and technical specs.
• Excellent problem solving, technical writing, and RCA skills.
• Good project management and cross-functional collaboration abilities.
• Certifications (CQE, Six Sigma, Lead Auditor) are a plus.

Responsibilities

• Collaborate with Operations to ensure high quality performance of products and processes.
• Serve as Quality representative on cross-functional teams to resolve issues.
• Lead NCs, CAPAs, and MRB dispositions with timely closure.
• Conduct risk management and support change management.
• Perform supplier audits and manage ASL and part approvals.
• Support internal/external audits and inspection readiness.
• Review and approve validation protocols and reports (equipment, process, MSAs).
• Monitor KPIs, analyze trends, and drive corrective actions.
• Support product transfers, EC changes, and field actions.
• Apply SPC and quality system methods; contribute to management reviews.
• Coordinate with Regulatory on IFUs and quality records.
• Mentor teams on GMP and best quality practices.
• Work in ERP to support purchasing, manufacturing, and quality processes.

Skills

Quality concepts

CAPA

Audits

Statistics

Root cause analysis

Project management

Cross-functional collaboration

GMP

Regulatory experience

Education

Bachelor’s degree in Engineering

Tools

CQE

Six Sigma

Lead Auditor

Job description

What You’ll Do:

• 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

What You Bring:

• 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
• Professional certifications (CQE, Six Sigma, Lead Auditor, etc.) are highly desirable

Why VB Spine?

We believe in growing talent from within. At VB Spine, join a high-performing team where you’ll play a critical role in ensuring the quality and safety of innovative spinal implants and instruments 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