Spectra force
Spectraforce is a leading global services firm that provides a portfolio of consulting, staffing and outsourcing services and solutions to a broad range of clients and industries worldwide. We are headquartered in Raleigh, NC, USA and have offshore global delivery centers in Pune, Chandigarh, Bangalore, and Hyderabad, India.
Job Description
Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / 14971 One or more years of experience with medical terminology, clinical or laboratory knowledge, and familiarity with client's products. Two or more years of experience in complaint handling, Medical Device industry, Customer relations, complaint trending, MDR submissions, FDA regulations, GMP. Skills: Strong analytical, deductive reasoning, and listening skills Must be able to communicate precisely and accurately to all levels of the organization Ability to speak multiple languages preferred, including Spanish, Portuguese, and French. Strong interpersonal skills with the ability to effectively lead a multi-functional audit team Qualifications
Education: BS Degree in Science or Engineering or Business, or applicable work experience Complexity of Duties: Duties are very complex in nature and pertain to the overall investigation of customer complaints. Under the direction of the Manager, Customer Management Center, manages activities and procedures associated with complaints concerning client's products. Accountable for setting own work direction and completing work tasks. Supervises the processing of customer complaints, including maintenance of complaint files, responses to customers, and Quality reports. Responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints, as well as supporting Market Segment Teams. Able to manage the end-to-end process of customer complaints, including utilization of the database systems used to process complaints. Responsibilities: Contributes to the business-wide quality strategy and quality objectives Maintains systems to monitor and facilitate the timely investigations and close out of complaints. Ensures systems workflow precludes lengthy unanswered complaints. Manages the process of the complaint handling system
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Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / 14971 One or more years of experience with medical terminology, clinical or laboratory knowledge, and familiarity with client's products. Two or more years of experience in complaint handling, Medical Device industry, Customer relations, complaint trending, MDR submissions, FDA regulations, GMP. Skills: Strong analytical, deductive reasoning, and listening skills Must be able to communicate precisely and accurately to all levels of the organization Ability to speak multiple languages preferred, including Spanish, Portuguese, and French. Strong interpersonal skills with the ability to effectively lead a multi-functional audit team Qualifications
Education: BS Degree in Science or Engineering or Business, or applicable work experience Complexity of Duties: Duties are very complex in nature and pertain to the overall investigation of customer complaints. Under the direction of the Manager, Customer Management Center, manages activities and procedures associated with complaints concerning client's products. Accountable for setting own work direction and completing work tasks. Supervises the processing of customer complaints, including maintenance of complaint files, responses to customers, and Quality reports. Responsible for a variety of mechanical and functional product evaluations related to the investigation of customer complaints, as well as supporting Market Segment Teams. Able to manage the end-to-end process of customer complaints, including utilization of the database systems used to process complaints. Responsibilities: Contributes to the business-wide quality strategy and quality objectives Maintains systems to monitor and facilitate the timely investigations and close out of complaints. Ensures systems workflow precludes lengthy unanswered complaints. Manages the process of the complaint handling system
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