Quality Engineer (KL)

Change peoples 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 peoples lives.

Cochlears 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 industrys best clinical research and support networks. Thats 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 lifes 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 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 3-5 years experiences working in Quality or manufacturing operations in regulated Medical Device industry; prior quality engineering experience in a Class III regulated environment is an added advantage.
• Minimum Bachelors 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 Cochlears 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.

Cochlear Malaysia provides shared services to support Cochlears 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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