Quality Engineer (KL)

Cochlear Malaysia Sdn Bhd; Kuala Lumpur; On-site; MYR 90,000 - 140,000; Full time

Job summary

Cochlear Malaysia Sdn Bhd is seeking a Quality Engineer (KL) to support regulatory compliance and manufacturing quality for Class III active implantable devices. You will partner with Manufacturing, Engineering and cross-functional teams to ensure the QMS and products meet global regulatory, customer and business needs.

This role suits a detail-oriented quality professional who enjoys problem-solving in a highly regulated medical device environment and wants to contribute to continuous

Qualifications

• Bachelor's degree in Engineering or Science is required.
• 2–5 years of experience in Quality or Manufacturing within regulated medical devices.
• Experience with NCR, CAPA and change control processes.
• Knowledge of ISO 9001, ISO 13485, FDA QSR, MDSAP and EU MDR.
• Strong data analysis and reporting skills; attention to detail.
• Internal auditor certification preferred; willingness to learn audits.
• Excellent written and spoken English is essential.

Responsibilities

• Ensure regulatory compliance across QMS and products with FDA 21 CFR Part 820 and ISO 13485.
• Assist in NCR investigations and CAPA for Class III devices across Manufacturing and Logistics.
• Identify improvements to maintain compliant, high-quality manufacturing and processes.
• Support internal and supplier audits and assist with external audits.
• Review and maintain QMS documents for proposed changes or product changes.
• Produce metrics and data analysis on non-conformances; deliver periodic reports.
• Collaborate with Process Engineering to design practical, risk-based quality plans.
• Deliver training on process changes and improvements to stakeholders.

Skills

Regulatory compliance

QMS knowledge

NCR/CAPA handling

Auditing (internal/external)

FMEA / risk analysis

Documentation skills

SPC / statistical methods

English proficiency

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Engineering or Science

Tools

Non-conformance tracking

CAPA management

Audit management tools

Job description

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 preferred. Candidates with limited audit experience are welcome, if demonstrate a willingness to learn and support internal and external audits. You should be able to understand audit findings and work with the team to help implement corrective actions.
• Demonstrates understanding of complex regulatory frameworks, including ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820), MDSAP, and EU MDR, with a proven ability to pragmatically apply regulatory requirements while balancing compliance rigor with efficient, effective manufacturing processes.
• Collaborating across multiple teams to resolve quality issues and implement sustainable improvements.

Why is this role right for you?

• At least 2-5 years of experience in Quality or Manufacturing Operations within a regulated Medical Device industry is preferred. Fresh graduates with a relevant academic background are also encouraged to apply.
• Minimum Bachelor's degree in Engineering or Science or equivalent.
• Direct hands‑on experience with Non‑Conformance, Concession, CAPA handling processes and product acceptance processes.
• Strong experience with Quality Management tools and techniques, including data analysis, metrics, and reporting; demonstrated ability to apply appropriate statistical methods is essential for this role.
• Awareness and practical application of regulations ISO9001, ISO13485, FDA QSR. Added advantage with knowledge on MDSAP and EUMDR regulations.
• Audit capability (for internal/external audit). Preferably trained Internal auditor (ISO 13485 or ISO 9001).
• Knowledge in Risk Management and or Change Management Process.
• Experience in continuous improvement projects. Highly developed analytical, problem‑solving and reporting skills.
• Knowledge of Quality and/or manufacturing operations in regulated industry.
• Strong organizational, interpersonal, and stakeholder management skills, with the ability to effectively influence, guide, and provide clear, constructive feedback to both internal and external stakeholders.
• Attention to details, maintain consistency, standards, accurate and complete documentation.
• Ability to work independently as well as in collaboration with other teams and departments.
• Good proficiency in writing procedural and technical documents.
• Excellent oral and written communication in English is a MUST in this role.

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.

Cochlear is an organisation you can be proud to be part of. Underpinning our position as a global market leader is the quality of our people. You will get to work with talented, friendly and supportive colleagues who are dedicated towards making a difference. We are an expanding workforce that has grown from only 500 in 2004 to more than 2,700 today. We have built our business to support over 200,000 recipients globally with direct operation in 20 countries and distribution in 100 countries. Leveraging our scale and global reach, we pursue a breadth of research and development activities that will bring the most significant technologies, products and services to market for our recipients. Currently we are involved in over 79 collaborative research programs, involving 131 centers across 19 countries.

For 30 years Cochlear has been the global leader in implantable hearing solutions. Our commitment to shaping the future of our industry means we work hard to achieve long-term sustainable financial growth. Every year we make significant investments in research and development, so we continually improve our products and stay at the leading edge of technological advancements. Testaments to our effective R&D undertakings are more than 100 registered patent families and multiple industry awards. Today, our products set new benchmarks in hearing performance with the most reliable implants on the market. As we continue to launch new products and revolutionise the industry, you will experience a new era of growth, change and opportunity right across the business. Now is truly an exciting and challenging time to join our transforming and growing business.