# Quality Engineer (KL) at Cochlear

Cochlear is hiring a Quality Engineer (KL) in Kuala Lumpur, Malaysia. Level rates it Little AI ●○○○; you can [apply on Cochlear](https://jobsbylevel.com/go/4bd79eef-d7b7-452b-8454-0605caa668ad?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. Kuala Lumpur.

## Details

- Company: [Cochlear](https://jobsbylevel.com/companies/cochlear)
- AI level: AI Level 1 (score 38 out of 100)
- Location: Kuala Lumpur
- Posted: October 7, 2026
- Apply: https://jobsbylevel.com/go/4bd79eef-d7b7-452b-8454-0605caa668ad?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=quality-engineer-kl-at-cochlear-fb5586

## Description

Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market-leader in implantable hearing devices, more people choose a Cochlear-branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. 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 We are seeking a motivated and detail-oriented Quality Engineer (KL) to support regulatory compliance and manufacturing quality for Class III Active Implantable Medical Devices. In this role, you will partner closely with Manufacturing, Engineering and cross-functional stakeholders to ensure our Quality Management System (QMS) and products consistently meet global regulatory, customer, and business requirements. This is an excellent opportunity for a quality professional who enjoys problem-solving, continuous improvement, and working in a highly regulated medical device environment. In this role you will be responsible for: Ensure regulatory compliance across the Quality Management System (QMS) and products by partnering with stakeholders, in particular providing guidance and training to stakeholders to meet FDA 21 CFR Part 820 and (EN) ISO 13485 (and related standards), EU MDR, MDSAP. Assist in identifying, evaluating, containing, investigating and applying corrective actions for Class 3 Active Implantable Medical Devices across Manufacturing and Logistics. Identify and implement improvements that will ensure Cochlear continues to effectively produce compliant products that satisfy customer, regulatory and business requirements, provide Quality System & Regulatory mentoring and direction to other departments. Support the Non-Conformance Report (NCR) process with regular problem-solving meetings to provide direction and support for the stakeholder. Assisting stakeholders in Concession implementation within the supporting areas. Support First Time Quality, Fast Response and Morning Market meetings. Conduct regular Internal or Supplier audits, supporting external audit. Review of QMS documents for proposed changes or product related changes. Produce key performance metrics and data analysis on Non-conformance reports. Ensure timely delivery of periodic reports and scheduled activities. Partner with Process Engineering and Validation teams to design Manufacturing Quality Plans that are practical and risk-based. Support MQP implementation and assess opportunity to tighten or reduce sampling. Ensure appropriate level of training is delivered for process changes and improvements. Position Specific Skills and Challenges Working in a highly regulated Class III medical device environment with strict compliance requirements. Managing and analyzing Non-Conformance Reports (NCRs) using risk-based problem-solving methodologies. Demonstrates a good understanding of quality tools and risk-based approaches, such as FMEA, root cause analysis, and basic statistical process control (SPC), with the ability to apply these tools to support quality improvement initiatives. Skilled in developing, reviewing, and maintaining high-quality procedural and technical documentation. Passionate about documentation accuracy, consistency, and standardization. Internal Auditor certification (ISO 13485 and/or ISO 9001) is

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/quality-engineer-kl-at-cochlear-fb5586

Source: https://jobsbylevel.com/jobs/quality-engineer-kl-at-cochlear-fb5586

## Cite this page

Level. https://jobsbylevel.com/jobs/quality-engineer-kl-at-cochlear-fb5586.

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