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Application Deadline
End Date: June 6, 2025 (25 days left to apply)
Job Requisition ID: R-621562
Important Note
Please submit your application as soon as possible, as we reserve the right to close this advertisement at any time.
About Cochlear
Cochlear is the global market leader in implant hearing solutions.
Our mission is to help people hear and be heard.
We offer the world's only products that restore a sense through technology, with more people choosing Cochlear than any other hearing implant system.
Join us to make a difference in people's lives worldwide.
Role Overview
The Quality Engineer ensures regulatory compliance across the Quality Management System (QMS) and products by partnering with stakeholders, providing guidance, and training to meet standards such as FDA 21 CFR Part 820 and ISO 13485.
Responsibilities include supporting problem-solving processes, identifying improvements, and ensuring product compliance and quality.
Key Responsibilities
Support NCR processes through regular problem-solving meetings.
Assist in First Time Quality, Fast Response, and Morning Market meetings, and support CAPA activities.
Participate in QMS Continuous Improvement activities, including process reviews and internal audits.
Develop and report on key performance metrics related to Non-Conformance Reports.
Collaborate with Process Engineering and Validation teams to design and implement Manufacturing Quality Plans.
Ensure timely delivery of reports and monitor process trends for escalation when necessary.
Translate quality requirements into effective training materials and deliver training to staff.
What Makes This Opportunity Unique
This role offers the chance to lead initiatives that promote consistency, standardization, and compliance within the Quality department, impacting product quality and customer satisfaction.
About You
We seek individuals passionate about delivering quality hearing solutions, with the following skills and experience:
Required Skills
Knowledge of QMS standards: ISO 9001, ISO 13485, FDA QSR.
Strong process analysis and problem-solving skills, applying risk-based methodologies.
Understanding of manufacturing quality processes.
Ability to work independently and collaboratively.
Desired Skills
Organizational and interpersonal skills for liaising with internal and external stakeholders.
Experience implementing QMS process improvements.
Quality engineering experience in regulated environments, especially Class 3 devices.
Proficiency in documentation and technical writing.
Education
Engineering or Science degree or equivalent.
Our Commitment
We value diversity and are committed to creating an inclusive environment.
We offer flexible working arrangements and support your professional growth.
Learn more about Life at Cochlear at our careers page.
Join Us
If you believe you have the skills and passion to succeed, apply now and be part of our mission to help more people hear and be heard.
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