Manufacturing Quality Control Specialist

Cochlear's mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry's best clinical, research and support networks. That's why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life's opportunities.

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

To succeed in this role, you will need to:

• Apply a strong understanding of ISO 13485, FDA 21 CFR Part 820 and GMP requirements in daily operations.
• Demonstrate meticulous attention to detail when reviewing and maintaining documentation.
• Analyze data, identify trends, and communicate insights clearly through reports and dashboards.
• Navigate multiple priorities and collaborate effectively across global and cross-functional teams.
• Manage change in a fast-paced environment while ensuring ongoing compliance.
• Adapt to evolving digital systems and tools to support quality and operational excellence.

Why is this role right for you?

This role will suit you if you:

• Are passionate about ensuring compliance and supporting the production of life-changing medical devices.
• Enjoy working with data, reports, and digital tools such as MES, ERP, QMS, and Power BI.
• Take pride in accuracy, structure, and quality documentation.
• Thrive in a collaborative environment where you can partner with global teams in Manufacturing, Engineering, and Quality.
• Are motivated by continuous improvement, innovation, and contributing to a mission-driven organization.
• Value autonomy and responsibility while maintaining a strong focus on compliance and detail.

Qualifications & Experience

• Bachelor's degree in Life Sciences, Engineering, or a related discipline.
• 1-2 years of experience in a similar role within a regulated manufacturing environment.
• Strong understanding of Quality Management Systems (QMS) and Good Documentation Practices (GDP).
• Experience with MES, ERP, and QMS platforms; experience in software UAT is an advantage.
• Proficiency in Microsoft Excel, Power BI, or similar data analysis tools.
• Excellent written and verbal communication skills in English are essential for this role.
• Demonstrated ability to work independently, manage multiple priorities, and communicate effectively across teams.

Cochlear Malaysia provides shared services to support Cochlear's global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering.

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below.