Quality Complaint Specialist
Indeio Indeio Cordova, TN Cordova, TN Full-time Full-time From $40 an hour From $40 an hour 2 days ago 2 days ago 2 days ago Due to tremendous growth, Indeio is looking for a Quality Complaint Specialist to analyze and act on information from complaint investigations About us:
We are a spirited, high-growth company focused on the success of our clients and our colleagues.
We put a new spin on consulting that allows our team to work at or with some of the world's largest and well-known medical device and pharmaceutical companies.
Responsibilities:
The Quality Complaint Specialist's primary function is analyzing and acting on information from complaint investigations Additionally, this role develops and implements processes and procedures that drive and ensure compliance with US and International requirements and is responsible for managing and monitoring the status of requests and tasks associated with quality compliance projects Investigate product complaints and adverse events to determine root cause and the need for corrective action Execute timely evaluation and submission of reportable product complaints and adverse events to regulatory authorities Communicate directly with notified body, internal/external customers, distributors, physicians, suppliers, and other manufacturers to ensure timely completion of activities related to complaint and failure investigations Ensure that policies and procedures comply with domestic, international and corporate standards Responsible for staying current on applicable regulations and incorporating any changes into policies and procedures Analyze post-production data for compliance with U.
S.
and international regulations and requirements (ISO 13485, 14971, etc.
) Maintain electronic quality management system/software for post-market surveillance to collect, monitor and trend data within areas of responsibility Monitor assigned projects and tasks to ensure compliance with regulatory agencies, protocols, agreements, and applicable corporate compliance requirements Uphold the highest ethical standards by doing our job compliantly, ethically, and in a manner that reflects our underlying values
Qualifications:
Bachelor degree in biology, health sciences, engineering, nursing or other related discipline with a minimum 5 years' experience in complaint handling and adverse event reporting Strong knowledge of quality system regulations (FDA QSR, ISO 13485) A broad understanding of regulatory and compliance issues that drive the medical device industry, including those outside of the area of his/her expertise Must possess good verbal and written communication skills with an investigative mindset and critical analysis skills Job Type:
Full-time Pay:
From $40.
00 per hour
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
We are a spirited, high-growth company focused on the success of our clients and our colleagues.
We put a new spin on consulting that allows our team to work at or with some of the world's largest and well-known medical device and pharmaceutical companies.
Responsibilities:
The Quality Complaint Specialist's primary function is analyzing and acting on information from complaint investigations Additionally, this role develops and implements processes and procedures that drive and ensure compliance with US and International requirements and is responsible for managing and monitoring the status of requests and tasks associated with quality compliance projects Investigate product complaints and adverse events to determine root cause and the need for corrective action Execute timely evaluation and submission of reportable product complaints and adverse events to regulatory authorities Communicate directly with notified body, internal/external customers, distributors, physicians, suppliers, and other manufacturers to ensure timely completion of activities related to complaint and failure investigations Ensure that policies and procedures comply with domestic, international and corporate standards Responsible for staying current on applicable regulations and incorporating any changes into policies and procedures Analyze post-production data for compliance with U.
S.
and international regulations and requirements (ISO 13485, 14971, etc.
) Maintain electronic quality management system/software for post-market surveillance to collect, monitor and trend data within areas of responsibility Monitor assigned projects and tasks to ensure compliance with regulatory agencies, protocols, agreements, and applicable corporate compliance requirements Uphold the highest ethical standards by doing our job compliantly, ethically, and in a manner that reflects our underlying values
Qualifications:
Bachelor degree in biology, health sciences, engineering, nursing or other related discipline with a minimum 5 years' experience in complaint handling and adverse event reporting Strong knowledge of quality system regulations (FDA QSR, ISO 13485) A broad understanding of regulatory and compliance issues that drive the medical device industry, including those outside of the area of his/her expertise Must possess good verbal and written communication skills with an investigative mindset and critical analysis skills Job Type:
Full-time Pay:
From $40.
00 per hour
Benefits:
401(k) Dental insurance Health insurance Paid time off Vision insurance Schedule:
8 hour shift Monday to Friday Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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