Global Supplier Quality Engineer II

Integra LifeSciences

Global Supplier Quality Engineer II improving supplier quality for Integra LifeSciences’ medical-device manufacturing. Conducting audits, managing CAPA and validations, and ensuring FDA/ISO compliance.

Posted 8/4/2026full-timePlainsboro • New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $71,300 - $97,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in supplier quality management, including conducting audits, maintaining compliance with GMP and ISO standards, and providing technical support across departments. Proficient in managing supplier non-conformances and leading continuous improvement initiatives within regulated environments.

Highest-signal resume keywords

Supplier Quality ManagementGMP ComplianceISO 9001 and ISO 13485 KnowledgeQuality Engineering SupportFDA Regulatory Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Supplier AuditsQuality AgreementsCAPAChange ManagementStatistical AnalysisValidation TechniquesNon-Conformance InvestigationMeasurement SystemsContinuous ImprovementAnalytical Tools

Soft Skills

Collaboration SkillsInterpersonal Communication

Industry Keywords

Medical DevicePharmaceuticalCGMPRegulatory RequirementsManufacturing EngineeringQuality ProjectsSupplier Management MeetingsMatrix EnvironmentTechnical DocumentationSupplier Change Requests

About the role

Key responsibilities & impact

Maintain the Approved Supplier List
Plan and execute supplier audits
Conduct supplier audits according to GMP, ISO standards, and regulatory requirements
Establish measurement systems to monitor supplier quality and reliability and prevent defects
Maintain Supplier Quality Agreements
Provide technical support to QC, purchasing, and production departments
Provide quality engineering support to suppliers, including audits, inspection techniques, validation, CAPA, and change management
Address Supplier Change Requests
Ensure outsourced process and product validation activities are performed and documented on schedule
Initiate, disposition, approve, and investigate supplier non-conformances
Escalate supplier quality issues and propose compliant solutions
Lead and participate in continuous improvement projects
Participate in internal and third-party audits and inspections
Manage or participate in quality projects
Support complaint investigations
Lead quarterly Supplier Management Meetings for the Columbia site

Requirements

What you’ll need

Bachelor’s or master's degree in manufacturing engineering, mechanical engineering, industrial engineering, sciences, or a related discipline is required
Minimum 3 years of experience in quality or manufacturing
Medical Device or Pharmaceutical experience is required
Experience or knowledge of ISO 9001 and ISO 13485 and 21 CFR 820 requirements preferred
Travel up to 25%, with possible international travel
Experience in an FDA- and other-regulatory-controlled environment
Strong collaboration skills and experience working in a matrix environment
Ability to read and understand technical and statistical documents
Ability to interface with technical and non-technical personnel
Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards
Experience using analytical tools for data-based decision-making

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Eligible employees and dependents may participate in company-sponsored benefit programs
Bonus, commission, equity or other variable compensation may be available