Nipro Medical India | Complaint Management Specialist | gurugram

4 days ago

gurugram, India Nipro Medical India Full time

Job Title: Complaint Management Specialist

Company: Nipro Medical India Pvt Ltd

Location: Gurgaon,

Department : Quality Assurance,

Reports To: Manager: QA/ QC/ RA


Company Overview:

Nipro Medical India Pvt Ltd is a subsidiary of Nipro

Corporation Japan - 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.


Position Overview:

The Complaint Management Specialist will be

responsible for managing and overseeing the complaint handling process for our

medical devices. This role is crucial in ensuring compliance with regulatory

requirements, improving product quality, and enhancing customer satisfaction.

The ideal candidate will have a strong background in quality assurance and

complaint handling in the medical device industry.


Key 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.


Qualifications:

- 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.


Preferred Qualifications:

- Certification in Certified Quality Engineer (CQE) , Quality Management (e.g., CQE, CQA), Certified Quality Auditor (CQA) Certified Manager of Quality/Organizational Excellence (CMQ/OE), Six Sigma Green Belt Certification and Certified Manufacturing Engineer (CMfgE)

- Familiarity with statistical analysis tools and techniques such as SQL, Statistical Analysis Software (SAS) etc


Benefits:

- Competitive salary and performance-based bonuses, Rewards & Recognitions

- Comprehensive insurance health, life and accident benefits

- Opportunities for professional development and career advancement.


Application Process:

Interested candidates are invited to submit their resume by email to

Email should mention "Complaint Management Specialist" in the subject line.

Only applications received by email be considered.


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