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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at ResMed. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our medical devices.
Key Responsibilities:- Support the development and implementation of quality management systems to ensure compliance with regulatory requirements.
- Conduct audits and assessments to identify areas for improvement and implement corrective actions.
- Collaborate with cross-functional teams to ensure quality and compliance throughout the product lifecycle.
- Develop and maintain quality procedures and documentation to ensure compliance with regulatory requirements.
- Provide training and support to employees on quality and compliance procedures.
- Bachelor's degree in a relevant field, such as quality assurance, engineering, or science.
- Minimum 2 years of experience in quality assurance, preferably in the medical device industry.
- Knowledge of ISO 13485 and EU MDR 2017/745 regulations.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Experience with CAPA and audit processes.
- Project management experience.
- Ability to think critically and make informed decisions.
- A competitive salary and bonus plan.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.