Quality Compliance Associate

Integra LifeSciences•Mansfield, MA

6d•$62,100 - $85,100

About The Position

The Quality Compliance Associate supports the site Quality Management System (QMS) by performing routine quality system and compliance activities in accordance with internal procedures and regulatory requirements. Primary responsibilities include supporting complaint handling and investigations, Nonconformance (NC) and CAPA processes, maintaining quality documentation, and providing quality assurance support to manufacturing and product development teams. This role works under the guidance of senior quality personnel and contributes to continuous improvement initiatives.

Requirements

Associate’s degree in a scientific, technical, or related discipline or a minimum of 2 years of experience working within a regulated industry (e.g., medical device, pharmaceutical, biotechnology, or similar).
Previous experience supporting quality systems, complaint handling, nonconformance management, or documentation control preferred.
Basic understanding of regulated quality environments (e.g., FDA, ISO, or similar standards).
Strong attention to detail and organizational skills with the ability to manage multiple tasks and meet deadlines.
Effective written and verbal communication skills.
Ability to clearly document findings and follow established procedures.
Must be able to read and write in English.

Responsibilities

Supports the maintenance of the site Quality Management System (QMS) to ensure compliance with applicable regulations, standards, and internal procedures.
Assists with complaint intake, documentation, investigation support, and timely closure in accordance with complaint handling procedures.
Supports the initiation, review, processing, and completion of Nonconformance (NC) records in the electronic quality system.
Gathers information and supporting data for complaint investigations, NCs, and CAPAs, and assists with root cause analysis activities.
Maintains quality system documentation, including procedures, forms, and records, ensuring accuracy and document control compliance.
Assists with quality data collection, trending, and reporting of quality metrics in accordance with established procedures.
Provides quality assurance support to manufacturing, product development, and other functional areas by addressing quality questions and ensuring procedural adherence.
Supports internal and external audits by preparing documentation, responding to requests, and participating as needed.
Participates in quality-focused meetings, communicates status updates, and tracks actions to completion.
Escalates potential quality issues, compliance risks, or delays to senior quality personnel in a timely manner.
Participates in continuous improvement activities and special projects as assigned.
Completes required training and maintains awareness of applicable quality system requirements and regulatory expectations.