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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.
The Opportunity
This position provides a service to ensure that the management of standards and requirements is conducted in accordance to process and of high quality in a Requirements Management tool called JAMA. This role engages with various stakeholders in R&D to understand requirements traceability and to produce high value reports and analysis in JAMA to ensure the effectiveness of the standards and requirements management processes.
Key Responsibilities:
- Manage the standards library in JAMA in accordance with applicable processes by ensuring the library is synchronized with the official standards register and that traceability to product development projects and other libraries is complete, consistent and correct.
- Collaborate with standards owners, system engineers and quality engineers across R&D to ensure that the standards library is adequately kept up to date with changes to existing standards or new standards.
- Prepare various reports as needed to demonstrate the completeness of the library and its applicability to relevant projects.
- Manage day-to-day tickets in relation to the maintenance of the library.
- Work with relevant stakeholders to implement process improvements relating to the management of the standards library for projects.
- Coordinate the process for adding, updating and removing requirements in accordance with applicable processes.
- Collaborate with system engineers and design engineers across R&D to identify methods, such as reports or new processes, to facilitate the analysis of the requirements library to ensure traceability, correct applicability to projects and quality.
- Working with stakeholders, initiate and manage the workflow for requirement reviews as well as to implement updates to requirements, test cases, traceability and functional designs in JAMA.
Essential Requirements:
- Bachelor’s Degree in Engineering/Science or related field, or equivalent.
- Minimum 5 years of experience in preferably in a highly regulated GMP manufacturing environment/ from medical device manufacturing industry will be an added advantage.
- Strong interest to work across various types of projects (systems, desktop software, mobile apps, firmware and hardware projects) and across various disciplines.
- Decent knowledge in product development, process flows, system engineering, managing enterprise software and database would be highly preferred.
- Ability to work independently with limited guidance.
- Excellent coordination, communication and stakeholder management skills.
- Experience working in a team-oriented, product development environment.
- Experience with the JAMA Requirements Management System or similar.
- Experience with systems engineering principles including requirements management and standards compliance.
- Experience working on projects in a regulated environment, ideally medical device or life science.
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.
#CochlearCareers
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