Senior Quality Engineer

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.
• 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.
• 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

• Awareness of complex regulations and practical application of regulations - ISO9001, ISO13485, FDA QSR, EU MDR, MDSAP. 
• Knowledge of Quality operations in a Class 3 regulated Medical Device industry.
• Preferably certified Internal auditor (ISO 13485 or ISO 9001)
• Knowledge in Risk Management and/or Change Management Process
• Good understanding of GMP.
• Understanding of IQC/FOA (First Off Approval) processes. Added advantage with knowledge on Plastic Molding processes.

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 industry and 3 years experiences working as Senior Quality Engineer.
• Experience with Quality Management tools and techniques, data analysis, metrics, reporting, application of appropriate statistical methods.
• Experience in managing Non-Conformance Report, Concession or CAPA handling processes.
• Highly developed audit capability/experience (for external or internal audit).
• Direct experience with implementation of improved or new QMS processes.
• 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.
• Highly developed analytical, problem-solving and reporting skills.
• Attention to details. Passion for consistency, standards, accurate and complete documentation.

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.

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.

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