Quality Assurance Manager
4 weeks ago
We are seeking a highly skilled QA Manager to join our team at Suvarna and Associates. The successful candidate will be responsible for ensuring the quality of our medical devices and implementing processes to enhance quality and efficiency.
Key Responsibilities:- Implement and manage Corrective and Preventive Actions (CAPA) processes to address product and process nonconformities.
- Evaluate and approve suppliers, conduct supplier audits, and monitor supplier performance.
- Ensure the quality of incoming materials through inspection and testing.
- Identify and implement process improvements to enhance quality and efficiency.
- Provide training on quality policies, procedures, and regulatory requirements.
- Manage the investigation of customer complaints and ensure timely resolution.
- Oversee activities to monitor product performance and safety in the field.
- Lead and mentor the QA team, providing guidance and support.
- Work with other departments to ensure quality objectives are met.
- Develop and track key quality metrics and generate regular reports for senior management.
- Bachelor's degree in engineering, life sciences, or a related field.
- Industry experience in the medical device industry with a focus on quality assurance, quality control, or regulatory affairs.
- Management experience in a managerial or supervisory role overseeing QA teams and processes.
- Regulatory knowledge of ISO 13485 and other relevant standards.
- Quality Management Systems (QMS): In-depth knowledge and experience in implementing and maintaining QMS.
- Auditing: Experience in conducting internal and external audits, including supplier audits.
- Problem Solving: Strong analytical skills for addressing quality issues and implementing corrective and preventive actions (CAPA).
- Documentation: Proficiency in developing, reviewing, and managing quality-related documentation.
- Communication: Excellent skills for coordinating with cross-functional teams, senior management, and regulatory bodies.
- Attention to Detail: High attention to detail to ensure compliance and product quality.
- Leadership: Strong leadership skills to effectively manage and mentor QA team members.
- Language Skills: Fluent in verbal and written English.
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