Global Supplier Quality Engineer – II

Integra LifeSciences

Global Supplier Quality Engineer II conducting supplier audits and ensuring quality compliance within manufacturing. Supporting supplier quality requirements for Integra's site in Columbia, MD.

Posted 5/24/2026full-timeColumbia • Maryland, New Jersey • 🇺🇸 United StatesMid-LevelSenior💰 $71,300 - $97,750 per yearWebsite

About the role

Key responsibilities & impact

Play a vital role supporting Supplier Quality by conducting supplier audits.
Maintain supplier quality requirements for Integra's manufacturing site in Columbia, MD.
Provide quality assurance leadership to select contract manufacturing sites and raw material suppliers.
Establish and ensure the Approved Supplier List is up to date.
Establish timely planning and execution of supplier audits.
Conduct Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements.
Ensure comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects.
Ensure Supplier Quality Agreements are up to date for applicable suppliers.
Provide Quality Engineering Support including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
Address Supplier Change Requests in compliance with procedures and regulatory requirements.
Ensure validation of outsourced processes/products are performed and documented according to procedures.
Ensure Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans.
Escalate supplier quality issues to management and propose solutions.
Participate in and lead continuous improvement projects and initiatives.
Support internal and third-party audits/inspections.
Manage or participate in quality projects as required.
Provide support with complaint investigations as required.
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 or 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, 21 CFR 820, requirements preferred.
Travel up to 25% with a possibility of international travel.
Experience in 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 to drive data-based decision making.

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
savings plan (401(k))

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

supplier auditsquality assurancequality engineeringCAPAchange managementvalidationinspection techniquesdata analysisregulatory compliancedefect prevention

Soft Skills

collaborationleadershipproblem-solvingcommunicationproject managementcontinuous improvementinterpersonal skillsmatrix environment experiencetechnical understandinginvestigation

Certifications

Bachelor's degreeMaster's degree