Senior Quality Specialist, QA Programs

Senior Quality Specialist, QA Programs

Job Description

Your Job

You’re not the person who will settle for just any role.

Neither are we.

Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference.

Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands.

In this role, you’ll help us deliver better care for billions of people around the world.

It starts with YOU. 

This role will lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) within the segment to ensure compliance with global standards and applicable regulatory requirements.

Drive technical quality excellence through effective execution of core quality processes, documentation control, and audit readiness, enabling superior consumer experience and operational performance.

Role Overview & Primary Accountabilities


* Key leadership responsibility for establishing, maintaining and making available the required QMS standards, procedures, processes and forms which make up the ISEA QMS.


* Own and maintain QMS processes including Change Control, Nonconformance, CAPA, Document Control, Training, and Complaints, ensuring compliance with enterprise standards and regulatory requirements.


* Manage Change Control and Design Management activities, ensuring proper evaluation, documentation, and approval of product and process changes in alignment with QMS and regulatory expectations.


* Lead management and analysis of post-market feedback (consumer complaints).

Identify trends and collaborate with cross-functional teams to implement corrective and preventive actions that improve consumer experience.


* Support External Contract Manufacturers (ECM) management, ensuring QMS compliance at third-party sites through documentation reviews, audits, and performance monitoring.


* Assist Supplier Quality Management by maintaining documentation, monitoring supplier performance, and supporting qualification and corrective action processes.


* Advise operations on operational controls and Good Manufacturing Practices (GMP) to ensure compliance, process capability, and prevention of quality issues.


* Execute and monitor quality programs at site/cluster level, ensuring timely and accurate deployment of updated standards and profiles in EtQ or equivalent eQMS.


* Facilitate the EM or ISEA Quality Management Review process by ensuring that accurate and relevant information is provided and analyzed and deliver actionable recommendations for improvement.


* Collaborate with the PMS leader to compile complaint data and market feedback for submission to regulatory authorities, ensuring full compliance with local regulations.

Organizational Scope and Interfaces



* Works closely with Cluster Quality Leaders, QA Program Leaders, and site Quality ope...