Senior Quality Engineer

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Cochlear Malaysia SDN BHD. (Malaysia) seeks a Senior Quality Engineer to ensure regulatory compliance across QMS and implanted devices. You will partner with Production and Engineering to maintain FDA 21 CFR Part820, ISO13485, and related standards while mentoring stakeholders.

Role includes driving CAPAs, NCRs, audits, and process improvements; you will work with cross-functional teams to ensure timely quality deliverables and robust documentation.

Qualifications

• Comprehensive understanding of ISO9001, ISO13485, FDA QSR (21CFR Part820), MDSAP, and EUMDR.
• Experience applying these standards in practical, real-world contexts.
• Strong in identifying gaps or risks in processes and implementing corrective actions.
• Ability to write precise procedural and technical documentation.
• Experience managing NCRs, CAPA, concessions and product acceptance processes.

Responsibilities

• Ensure regulatory compliance across the QMS and products; guide stakeholders to meet standards.
• Identify, evaluate, contain, investigate and apply corrective actions for Class3 devices.
• Support NCR processes with problem-solving meetings and stakeholder direction.
• Assist in concessions within relevant areas and support MQP implementation.
• Facilitate First Time Quality, Fast Response and Morning Market meetings.
• Conduct internal audits and support external audits.
• Review QMS documents for changes and product-related updates.
• Design Manufacturing Quality Plans in collaboration with Process Engineering and Validation teams.
• Produce KPIs and data analysis on NCRs and QMS performance.

Skills

Regulatory knowledge

Auditing

Risk management

Documentation

Stakeholder management

Quality improvement

Education

Bachelor’s degree in Electrical / Mechanical Engineering

Tools

Excel

Power BI

MES

ERP

QMS platforms

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. 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 21CFR Part820 and (EN)ISO13485 (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, and provide Quality System & Regulatory mentoring and direction to other departments.

• Ensure regulatory compliance across the Quality Management System (QMS) and products by partnering with stakeholders, providing guidance and training to stakeholders to meet FDA 21CFR Part820 and (EN)ISO13485 (and related standards), EUMDR, MDSAP.
• Assist in identifying, evaluating, containing, investigating and applying corrective actions for Class3 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 ISO9001, ISO13485, FDA QSR (21CFR Part820), 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 Class3 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 (ISO13485 or ISO9001). 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 and interpersonal skills, with the ability to effectively liaise and provide clear, constructive feedback to internal and external stakeholders regarding project issues.

Why is this role right for you?

• Minimum Bachelor’s degree in Electrical / Mechanical Engineering or equivalent.
• At least 6 years experiences working in Quality or manufacturing operations in regulated Medical Device industry (preferably with Class3 devices), including a minimum of 4 years experiences working as Senior Quality Engineer.
• Experience with Quality Management tools and techniques, data analysis, metrics, reporting, application of appropriate statistical methods.
• Hands‑on experience in managing Non‑Conformance Reports (NCRs), Corrective and Preventive Actions (CAPA), concessions, product acceptance processes.
• Highly developed audit capability/experience (for external or internal audit).
• Direct experience in identifying, implementing, and improving Quality Management System (QMS) processes, including collaboration with New Product Introduction (NPI) and Validation teams on Manufacturing Quality Plans (MQP).
• Highly developed analytical, problem‑solving and reporting skills.
• High proficiency in writing procedural and technical documents.
• Able to work independently as well as in collaboration with other teams and departments.
• Proficient in Stakeholder management; excellent organizational and interpersonal skills and capable of providing guidance/feedback to stakeholders.
• Attention to details.
• Passion for consistency, standards, accurate and complete documentation.
• Proficient in data analysis using Microsoft Excel, Power BI, or similar tools, with hands‑on experience in MES, ERP, and QMS platforms.

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.