Complaint Specialist (m/f/d)
Complaint Specialist (m/f/d)
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
In compliance with European MDD/MDR FDA & other International Regulations the Complaints Specialist will perform work under general management supervision. General scope of this position is to ensure compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting complaint followup coordination of complaint device returns and collaboration with the crossfunctional engineers and technicians for timely completion of the complaint investigation. This position requires frequent use and general knowledge of industry practices techniques and standards.
Tasks
Primary Responsibilities
- Processing of customer feedback (complaints) taking into account the requirements of ISO 13485 and all relevant medical device regulations
- Central recording of information by customers and sales/marketing Novanta about malfunctions and application problems. Problems with Novanta products (especially medical devices) as a complaint file
- Analysis of defective products (internal and customer supplier complaints) using quality tools (8D report 5WHY and others)
- Evaluation of the analysis results to develop and initiate corrective and preventive measures
- Evaluation of the analysis results with regard to complaint category (A B C or D) information to RA and QMB/safety commissioned for categories C and D
- Reporting to the customer (and the relevant internal areas)
- Documentation of processes in accordance with regulatory requirements
- Regular evaluation of processes (monthly and annually)
- Processing customer feedback on nonmedical devices (taking into account the requirements from ISO 9001)
- Recording analyzing evaluating and documenting customer feedback on nonmedical products
- Close cooperation with Quality Operations Supervisor and quality engineer Supervisor
- Working with SAP different operations (e.g. complaints material etc.)
- Participates in meetings for the launch of new projects
- Cooperation on customer internal quality audits
- Different types of analysis (scrap error rate).
Requirements
Primary Responsibilities
- Processing of customer feedback (complaints) taking into account the requirements of ISO 13485 and all relevant medical device regulations
- Central recording of information by customers and sales/marketing Novanta about malfunctions and application problems. Problems with Novanta products (especially medical devices) as a complaint file
- Analysis of defective products (internal and customer supplier complaints) using quality tools (8D report 5WHY and others)
- Evaluation of the analysis results to develop and initiate corrective and preventive measures
- Evaluation of the analysis results with regard to complaint category (A B C or D) information to RA and QMB/safety commissioned for categories C and D
- Reporting to the customer (and the relevant internal areas)
- Documentation of processes in accordance with regulatory requirements
- Regular evaluation of processes (monthly and annually)
- Processing customer feedback on nonmedical devices (taking into account the requirements from ISO 9001)
- Recording analyzing evaluating and documenting customer feedback on nonmedical products
- Close cooperation with Quality Operations Supervisor and quality engineer Supervisor
- Working with SAP different operations (e.g. complaints material etc.)
- Participates in meetings for the launch of new projects
- Cooperation on customer internal quality audits
- Different types of analysis (scrap error rate).
Employment Type
Full Time
