Senior Quality Assurance Engineer – Medical Devices

Integra LifeSciences Corporation; Plainsboro Township (NJ); Hybride; USD 71 000 - 98 000; Plein temps

Résumé du poste

Integra LifeSciences Corporation in Plainsboro, NJ seeks a Quality Assurance Engineer II to support the CMC Quality System. You will monitor NCs/CAPAs, guide investigations, and ensure compliant closure with FDA/ISO requirements.

Ideal candidates have 3–5+ years in medical device QA, strong documentation skills, and the ability to work independently in a fast-paced environment. On-site role with comprehensive benefits.

Qualifications

• Bachelor's degree in science or engineering; biomedical, mechanical, chemical, or electrical preferred.
• Experience in quality assurance for medical device/pharma manufacturing.
• Knowledge of investigations, root cause analysis, CAPA and quality systems.
• Strong writing, organization and communication skills.

Responsabilités

• Quality and technical review of NCs and CAPAs within defined timeframes.
• Maintain a log of Non-Conformances and CAPAs; track closures.
• Provide guidance and training on quality system activities.
• Ensure documentation is complete before closure.
• Assist Quality Systems in investigating nonconformances and CAPA implementation.
• Prepare monthly/quarterly quality metrics for reviews.
• Coordinate with cross-functional teams and regulatory requirements.

Connaissances

Investigations

Root cause analysis

Quality systems

CAPA

Technical writing

MS Office

Statistics

Formation

Bachelor’s Degree in Science or Engineering

Outils

MS Office

Statistical software

Description du poste

Integra LifeSciences Corporation in Plainsboro, NJ seeks a Quality Assurance Engineer II to support the CMC Quality System. You will monitor NCs/CAPAs, guide investigations, and ensure compliant closure with FDA/ISO requirements.

Ideal candidates have 3–5+ years in medical device QA, strong documentation skills, and the ability to work independently in a fast-paced environment. On-site role with comprehensive benefits.