Job no: 615816
Work type: Permanent
Location: Kuala Lumpur
Categories: Quality & Regulatory, Asia Pacific, Individual Contributor
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.
To support the growth in Manufacturing, we have a fantastic opportunity for a Quality Engineer to work in Cochlear Malaysia. You will be responsible 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)
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).
- 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.
- 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.
- At least 1-3 years experiences working in Quality or manufacturing operations in regulated industry.
- Minimum Bachelor’s degree in Engineering or Science or equivalent.
- Experience with Quality Management tools and techniques, data analysis, metrics, reporting, application of appropriate statistical methods is a MUST for this role
- Awareness and practical application of regulations ISO9001, ISO13485, FDA QSR. Added advantage with knowledge on MDSPA and EUMDR regulations.
- Knowledge of Quality and/or manufacturing operations in regulated industry.
- Good understanding of GMP.
- Knowledge in Risk Management and or Change Management Process
- Knowledge of how to analyse processes and identify issue.
- Experience in continuous improvement projects. Highly developed analytical, problem-solving and reporting skills.
- Good proficiency in writing procedural and technical documents.
- Excellent oral and written communication in English is a MUST in this role.
- Good organisational and interpersonal skills: ability to competently liaise and provide feedback to internal and external customers regarding project issues.
- Stakeholder management; Influencing skills, providing guidance to stakeholders
- Attention to details, maintain 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.
Advertised: Singapore Standard Time
Anticipated Application Closing: Singapore Standard Time
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