Change lives with a global medical device leader. Cochlear is the market leader in implantable hearing solutions, and our mission is to help people hear and be heard. We are seeking a meticulous Manufacturing Quality Control Specialist to join our Global Quality team. In this key role, you will ensure the highest standards of quality and compliance for our life-changing medical devices by reviewing batch records, managing digital documentation, and supporting the release of products to the world.
Key Responsibilities
You will be a crucial link in our global manufacturing network, ensuring product quality and regulatory compliance.
Quality Review & Documentation:
- Review Device History Records (DHRs) and batch documentation for accuracy, completeness, and compliance with ISO 13485 and FDA 21 CFR Part 820.
- Maintain controlled documents in the Electronic Document Management System (EDMS), ensuring version control and audit readiness.
- Collaborate with Manufacturing, Engineering, and Quality teams to resolve documentation discrepancies and support product release decisions.
Data Analysis & Systems Support:
- Collect, analyze, and report quality performance metrics from global manufacturing sites.
- Support data migration and User Acceptance Testing (UAT) for critical manufacturing and quality systems (MES, ERP, QMS).
- Utilize data analysis tools like Microsoft Excel and Power BI to identify trends and generate insights.
Continuous Improvement:
- Contribute to continuous improvement initiatives by identifying process gaps and supporting the implementation of effective solutions.
- Adhere to all quality procedures to ensure the delivery of safe, effective, and compliant outcomes.
Your Skills and Experience
Essential Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or a related field.
- 1–2 years of experience in a quality control or assurance role within a regulated manufacturing environment (medical device, pharmaceutical, etc.).
- Strong understanding of Quality Management Systems (QMS) and Good Documentation Practices (GDP).
- Proficiency with Microsoft Excel; experience with MES, ERP, or QMS platforms is advantageous.
- Excellent written and verbal communication skills in English.
Desired Profile:
- Meticulous attention to detail and a passion for working with data and digital systems.
- Ability to work independently, manage multiple priorities, and collaborate effectively in a global, cross-functional team.
- Motivated by a sense of purpose and contributing to a mission-driven organization.
Why Cochlear?
- Meaningful Work: Your work directly contributes to creating medical devices that change people's lives.
- Global Impact: Be part of a global team in our Malaysian shared services centre, supporting operations worldwide.
- Innovation & Growth: Thrive in a collaborative environment that values continuous improvement and professional development.
Ready to make a difference? If you have the skills and motivation to succeed in this high-impact role, we encourage you to apply.
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