Senior Quality Engineer

Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Cochlear Malaysia SDN BHD. (Malaysia) is seeking a Senior Quality Engineer to ensure regulatory compliance across the Quality Management System and products, partnering with stakeholders to meet FDA 21 CFR Part 820 and EN ISO 13485 and related standards.

The role supports Production and Engineering in identifying, evaluating and solving quality issues, implementing corrective actions, and driving Quality System improvements with risk-based methods.

Qualifications

• Strong knowledge of ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820), MDSAP, and EU MDR.
• Experience in NCR handling and corrective actions.
• Proficient in documentation and procedural writing.
• Auditing skills for internal and external audits.

Responsibilities

• Ensure regulatory compliance across QMS and products.
• Identify, evaluate, contain, investigate, and apply corrective actions for Class 3 devices.
• Support NCR process with problem-solving meetings and Concession implementation.
• Support First Time Quality and audit activities.
• Conduct internal audits and manage external audits.
• Review QMS documents and propose changes.
• Initiate and implement improvements to QMS processes.
• Produce KPIs and data analysis on NCRs and reports.

Skills

Regulatory compliance

Quality management systems

Audit management

Documentation

Tools

FMEA

Root cause analysis

Statistical process control

Job 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 an individual to join our fast paced as Senior Quality Engineer to 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)

The role will provide ongoing support to Production and Engineering teams when potential quality issues are identified. This role responsible to 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.

In this role you will be responsible for:

• Ensure regulatory compliance across the Quality Management System (QMS) and products by partnering with stakeholders, 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.
• 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 audit and managing External audit.
• Review of QMS documents for proposed changes or product related changes.
• Identify, initiate and implement improvements to QMS processes.
• 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

Demonstrated comprehensive understanding of complex regulatory frameworks, including ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820), MDSAP, and EUMDR, with proven ability to effectively apply these standards in practical, real-world contexts. Strong capability in analyzing processes and issues to identify gaps or risks. Proficient in managing Non-Conformance Reports (NCRs), applying risk-based methodologies and utilizing quality tools such as FMEA, root cause analysis, and statistical process control to identify, assess, and develop effective solutions for quality and compliance issues. Skilled in developing, reviewing, and maintaining high-quality procedural and technical documentation. Passionate about documentation accuracy, consistency, and standardization. Working knowledge of quality practices in a Class 3 regulated Medical Device manufacturing environment, including design transfer, establishing requirements, Manufacturing Quality Planning (MQP), process monitoring and a strong understanding of IQC/FOA (Incoming Quality Control/First Off Approval) processes, Risk Management and/or Change Management Process. Preferably certified Internal auditor (ISO 13485 or ISO 9001). Highly developed auditing skills with experience conducting and supporting both internal and external audits. Proficient in accurately interpreting findings and driving corrective actions to timely and effective closure. Highly proficient in writing precise procedural and technical documents, driven by a passion for consistency, adherence to standards, and maintaining accurate, complete documentation. Demonstrates strong independence in managing tasks while collaborating seamlessly across teams and departments to achieve shared goals. Excellent organizational