Weekend Lead Quality Inspector - QC Leadership & Training

integralife; Plainsboro Township (NJ); On-site; USD 36,000 - 48,000; Full time

Job summary

Integra LifeSciences seeks a Weekend Lead, Quality Inspector for the Plainsboro Manufacturing Site (CMC). The Lead Associate will supervise QC inspections of components, sub-assemblies and finished products, train inspectors, and ensure compliance with FDA, ISO 9001, ISO 13485 and related regulations.

Shifts are Fri–Sun 6:00 AM–6:30 PM (40-hour compensation). Responsibilities include scheduling inspections, addressing non-conformances, supporting CAPA investigations, coordinating with

Qualifications

• Minimum of 5+ years' experience in document management using electronic document management systems or manual systems with electronic storage.
• Minimum of 5+ years’ experience in a Quality Systems / Regulatory Compliance environment with knowledge in medical device, diagnostics or pharmaceutical industries; familiarity with FDA regulations and ISO quality standards.

Responsibilities

• Oversee daily activities in the QC department.
• Prepare the QC Inspection schedule to ensure manufacturing areas are covered to meet production schedule.
• Report non-conformances in a timely manner.
• Support NCs and CAPA investigations as required.
• Assist with product flow between departments.
• Coordinate inspections with Manufacturing to ensure timely completion.
• Propose revisions to SOPs for new processes or improvements.
• Train QC Inspectors as required.
• Perform inspections (incoming, in-process, first article, etc.) using inspection equipment to determine acceptance or rejection.

Skills

Document management

Quality systems

Communication skills

Microsoft Office

Tools

Oracle R12/Agile

Job description

Integra LifeSciences seeks a Weekend Lead, Quality Inspector for the Plainsboro Manufacturing Site (CMC). The Lead Associate will supervise QC inspections of components, sub-assemblies and finished products, train inspectors, and ensure compliance with FDA, ISO 9001, ISO 13485 and related regulations.

Shifts are Fri–Sun 6:00 AM–6:30 PM (40-hour compensation). Responsibilities include scheduling inspections, addressing non-conformances, supporting CAPA investigations, coordinating with