Our Client is looking for Quality complaint Investigator

Below are the details for this Job profile.

Key Responsibilities :

• Manage customer relationships and expectations during the course of complaint investigation and resolution process
• Research, seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments / business units for complaint investigations
• Evaluate complaints for Medical Device Reporting (MDR); prepare and submit MDR reports to FDA
• Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and / or training materials, and formulate conclusions
• Prepare and submit final customer correspondence
• Assist in planning agendas and running weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.

to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint

Additional Skills :

• Experience working in a medical device (cardiovascular, endovascular, or other critical care / surgical products), healthcare, or a related environment required
• Proven expertise in MS Office Suite and ability to operate general office machinery
• Demonstrated problem-solving , critical thinking, and investigative skills
• Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
• Good knowledge of medical terms and human anatomy
• Full knowledge of Medical Device Reporting regulations, and regulatory reporting regulations
• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing
• Ability to manage confidential information with discretion
• Work is performed independently on complex work and reviewed for accuracy and soundness

Education and Experience :

• Bachelor's Degree or equivalent in related field
• 1 years of experience required

Last updated : 2024-06-04