Medical Device Complaint Resolution Specialist
4 days ago
Job Title: Medical Device Complaint Resolution Specialist
About Us:
Nipro Medical India Pvt Ltd is a leading medical device manufacturing company dedicated to providing innovative and high-quality products that improve patient outcomes. We are committed to maintaining the highest standards of quality and compliance in our operations.
Job Summary:
We are seeking a highly skilled Medical Device Complaint Resolution Specialist to join our Quality Assurance team. This role is crucial in ensuring compliance with regulatory requirements, improving product quality, and enhancing customer satisfaction.
Responsibilities:
- Manage the intake, investigation, and resolution of customer complaints related to medical devices.
- Ensure compliance with CDSCO regulations, ISO standards, and company policies throughout the complaint handling process.
- Conduct thorough investigations of complaints, including root cause analysis and corrective action implementation.
- Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to address product issues and improve quality.
- Prepare and maintain detailed documentation of complaint investigations and resolutions in accordance with regulatory requirements.
- Monitor and analyse complaint trends to identify areas for improvement and develop preventive actions.
- Serve as the primary point of contact for regulatory agencies regarding complaint-related inquiries.
- Provide training and support to internal teams on complaint handling procedures and compliance requirements.
- Assist in the preparation of reports for management review and regulatory submissions.
Requirements:
- Bachelor's degree in Life Sciences, Engineering, Quality Assurance, or a related field.
- Minimum of 5 years' experience in complaint management, quality assurance, or regulatory affairs within the medical device industry.
- Strong knowledge of CDSCO (Medical Device regulations), ISO 13485 , ISO 27001 , QMS, Risk Management and other relevant quality standards.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work collaboratively in a team environment and manage multiple priorities.
- Proficient in using quality management systems and complaint handling software.
Benefits:
- Competitive salary range of ₹8-12 lakhs per annum, based on experience.
- Comprehensive insurance health, life, and accident benefits.
- Opportunities for professional development and career advancement.
How to Apply:
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