
Responsibilities
• Manage the QA/RA team
• Author and refine procedures, instructions, templates, and our quality manual to maintain quality management standards
• Maintain and monitor our quality system within the company: changes, CAPA, Non conformities, Complaints, PMS, continuous improvement, trend analysis, etc.
• Train all employees to the QMS, and assess skills, knowledge and QMS application.
• Perform internal audits to assess the company compliance with our QMS.
• Contribute to maintaining quality system related documentation including supplier records, audits, purchase and manufacturing batch information.
• Work with our Notified Body to maintain current certifications and achieve award of a CE mark and FDA approval on new products.
• Build knowledge and maintain surveillance of the many relevant quality standards
• Provide technical support and resolve quality issues with suppliers, customers or auditors including introduction of new or re-designed components and processes.
• Present technical data to internal / external audit and inspection groups as required.
Requirements
• Minimum of 5 years of Medical device QA/RA experience
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Quality Management experience in a manufacturing/production environment.
• Conscientious and responsible
• A keen eye for detail and a results driven approach
• Strong communication and presentation skills.
• Excellent organizational and leadership skills
• Proficient in MS Office
• In depth understanding of quality control procedures and relevant legal standards
• Excellent math abilities and working knowledge of data analysis/statistical methods

About Hunarstreet Technologies Pvt Ltd
About
At Hunarstreet Technologies Pvt Ltd, we specialize in delivering India’s fastest hiring solutions, tailored to meet the unique needs of businesses across various industries. Our mission is to connect companies with exceptional talent, enabling them to achieve their growth and operational goals swiftly and efficiently.
We are able to achieve a success rate of 87% in relevancy of candidates to the job position and 62% success rate in closing positions shared with us.
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Solid understanding of microservices architecture and distributed systems.
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Strong problem-solving skills and ability to write optimized, production-grade code.
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Candidates who enjoy building systems from scratch and working in early-stage/startup environments.
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Managing a portfolio of SME clients, monitoring their insurance needs, and
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Identifying and pursuing new business opportunities within the SME sector to grow
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Well Experienced & Familiarity with the unique needs and challenges of SME
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Behavioral Competencies:
• Excellent English written / verbal communication skills
• Design thinking and Analytical Approach
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and execution of day-to-day work and work as an IC with minimal guidance on occasions
• Strong problem detection/solving abilities.









