Quality Assurance Specialist
2 weeks ago
Quality Assurance Role Overview
The Quality Assurance function at ResMed is responsible for ensuring that our management systems are established to enable business compliance with multiple regulatory frameworks and to support the design, development, and manufacture of products that meet our customer's quality requirements.
Key Responsibilities
- Support the implementation of the Quality Management Systems in EMEA to ensure compliance with applicable regulatory standards and business requirements.
- Manage quality activities and actions within the framework of the processes constituting the Quality Management Systems in EMEA.
- Contribute to establishing and maintaining metrics and feedback mechanisms to monitor the continued effectiveness of the QMS in EMEA.
- Promote a culture of quality through continuing education, consultation, and contributing to management review.
- Build positive working relationships with cross-functional project teams to ensure Quality System Team activities are recognized as an integral part of business success and growth.
Requirements
- Bachelor's degree or Master in Science, Quality, or Engineering.
- Minimum 2 years of applied professional quality assurance experience, ideally including the medical industry.
- Experience with ISO 13485 Medical Standard and knowledge of EU MDR 2017/745 & local regulations.
- Experience with CAPA and Audits.
- Strong planning and organization skills.
- Strong listening, verbal, and written communication skills.
Preferred Qualifications
- Ability to identify linkages and dependencies between processes.
- Experience in the maintenance of Management Systems, including ongoing improvement of systems and processes.
- Project management experience.
- Ability to think clearly and critically, assess information and evidence to make informed, timely decisions.
Additional Information
- At ResMed, all employees benefit from a bonus plan, the percentage of which depends on your position within the organisation.
- Working from home flexibility.
- You also have access to a referral bonus and to ResMed's preferred shareholding programme.
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