Manufacturing Quality Control Specialist

Manufacturing Quality Control Specialist

Cochlear Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Cochlear's mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to providing people with moderate to profound hearing loss a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies, while collaborating with the industry's best clinical, research and support networks.

The Opportunity

Join Cochlear's Global Quality team and play a key role in ensuring the highest standards of product quality, compliance, and operational excellence. As a Manufacturing Quality Control Specialist (KL), you will support our global manufacturing network by reviewing batch records, managing digital quality documentation, and ensuring the timely and compliant release of life‑changing medical device products.

This position offers the opportunity to work collaboratively across teams while exercising autonomy and initiative in a regulated, high‑impact environment.

In this role you will be responsible for :

• Reviewing Device History Records (DHRs) and batch documentation to ensure accuracy, completeness, and compliance with regulatory and internal standards.
• Collaborating with manufacturing, engineering, and quality teams to resolve documentation discrepancies and support product release decisions.
• Maintaining controlled documents in the electronic document management system (EDMS), ensuring version control and audit readiness.
• Collecting, analyzing, and reporting quality performance metrics across global manufacturing sites.
• Supporting data migration and User Acceptance Testing (UAT) for manufacturing and quality systems such as MES, ERP, and QMS.
• Contributing to continuous improvement initiatives by identifying process gaps and supporting implementation.
• Following quality procedures to deliver compliant, safe, and effective outcomes.

Position Specific Skills and Challenges

Why is this role right for you?

Qualifications & Experience

Cochlear Malaysia provides shared services to support Cochlear's global operations, including IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, and service and repairs.

Seniority level

Employment type

Job function

Industries

#J-18808-Ljbffr