Site Quality Leader | CAPA, Audits & Compliance

Integra LifeSciences; Prospect (CT); On-site; USD 95,000 - 130,000; Full time

Job summary

Integra LifeSciences seeks a QA professional to lead critical Quality areas in the Prospect, CT facility. You will drive CAPA, Change Control, and documentation control to ensure compliant product manufacturing and timely issue resolution.

You will provide QA on-the-floor support to Operations and QC, participate in audits and inspections, and help maintain the Quality Management System in a regulated environment. Strong writing and communication skills are essential.

Qualifications

• BS degree in Engineering, Math, or Science with 5+ years in QA/Quality Control.
• Minimum of 5 years in a regulated industry, preferably Medical Device.
• Working knowledge of QA elements related to QA Engineering (CAPA, CoNforming Product, Change Control, Validation, Quality Control).
• Experience with measurement systems and statistical techniques to support Quality Control.
• Experience leading CAPA investigations.
• Working knowledge of medical device regulations (FDA QSRs, ISO13485).
• Strong communication and technical writing skills.
• Proficiency with MS Office Suite, including Visio and Project.

Responsibilities

• Lead CAPA investigations and effectiveness verification.
• Oversee Control of Nonconforming Product (disposition, containment) processes.
• Evaluate impact and risk assessments related to CAPA/NCMR.
• Provide on-the-floor QA support to Operations, Manufacturing Engineering, and QC.
• Support new product development and production with Change Control.
• Assist in validations for new and existing products, processes and equipment.
• Lead Quality representations on projects and meetings.
• Maintain Quality Management System procedures.

Skills

CAPA

Change Control

Control of Nonconforming Product

Quality System

Documentation

Education

BS degree in Engineering/Math/Science

Tools

MS Visio

MS Project

Job description

Integra LifeSciences seeks a QA professional to lead critical Quality areas in the Prospect, CT facility. You will drive CAPA, Change Control, and documentation control to ensure compliant product manufacturing and timely issue resolution.

You will provide QA on-the-floor support to Operations and QC, participate in audits and inspections, and help maintain the Quality Management System in a regulated environment. Strong writing and communication skills are essential.