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Manager - Quality Assurance - Healthcare
4 weeks ago
- This is a full-time on site role for a Quality Assurance Manager.
- The Quality Assurance Manager will be responsible for overseeing quality assurance processes, developing and implementing quality management systems, conducting audits, ensuring regulatory compliance, and managing a team of quality assurance specialists.
- The Manager will also analyze data to identify areas for improvement and ensure the continuous improvement of products and processes.
Qualifications:
- Experience in Quality Assurance and Quality Management Systems.
- Skills in conducting audits and ensuring regulatory compliance.
- Strong analytical skills to identify areas for improvement.
- Team management and leadership skills.
- Excellent written and verbal communication skills.
- Ability to work independently and remotely.
- Experience in the healthcare or medical device industry is a plus.
- Bachelor's degree in Engineering, Science, or related field.
Must Have:
- Experience in certification of Class 2B and Class C Medical devices.
- Minimum experience of at least 5 years in the field of QA/QC.
- Knowledge of Electronics and Programming.
- Managed a team of at least 5 members.
- Knowledge of ISO 13485, IEC 60601, IEC 80601.
- Should be aware of process of CE FDA & CDSCO.
