Site Quality Leader - Medical Device QA & CAPA

INTEGRA LIFESCIENCES CORP; Prospect (CT); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) plan

Job summary

Integra LifeSciences seeks a qualified Quality Assurance professional to lead critical QA activities in support of manufacturing and operations at our Prospect, CT site. This role emphasizes CAPA, Change Control, Control of Nonconforming Product, Validation, and Documentation Control, with on-the-floor QA support for Operations and Manufacturing Engineering.

Strong regulatory knowledge and communication skills are essential for success.

Qualifications

• BS degree in Engineering, Math, or Science with 5+ years in Quality Assurance/Control.
• Experience in regulated industries, preferably Medical Device.

Responsibilities

• Lead key QA areas including CAPA, Change Control, NCMR, and Document Control.
• Provide QA on-the-floor support to Operations and Manufacturing Engineering.
• Support validations for new and existing products, processes, and equipment.
• Lead audits and participate in FDA inspections and ISO surveillance audits.
• Identify opportunities for continuous improvement and report metrics.

Skills

QA Engineering

CAPA investigations

On-the-floor support

Cross-functional teamwork

Technical writing

Education

BS in Engineering/Math/Science

Tools

MS Office

MS Visio

MS Project

Job description

Integra LifeSciences seeks a qualified Quality Assurance professional to lead critical QA activities in support of manufacturing and operations at our Prospect, CT site. This role emphasizes CAPA, Change Control, Control of Nonconforming Product, Validation, and Documentation Control, with on-the-floor QA support for Operations and Manufacturing Engineering.

Strong regulatory knowledge and communication skills are essential for success.