Complaint Specialist

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Summary

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 follow-up, coordination of complaint device returns, and collaboration with the cross-functional engineers and technicians for timely completion of the complaint investigation. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Primary Responsibilities
- Processing of customer feedback (“complaints”), taking into account the requirements of ISO 13485 and all relevant medical device regulations
- 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 non-medical devices (taking into account the requirements from ISO 9001)
- Recording, analyzing, evaluating and documenting customer feedback on non-medical 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).

Required Experience, Education, Skills, Training and Competencies
- Knowledge of EN ISO 13485 and EN ISO 9001 standards
- Knowledge of quality tools (5Why, Ishikawa, 8D report)
- Orientation in technical documentation
- Knowledge and active uses of the MS office package
- Focused, reliable and independent working style
- Active approach and participation in the innovation process
- Strict compliance with quality, safety and environmental regulations and implementation of the instructions of quality
- German and English language very good (used daily)

Travel Requirements
- The willingness to travel to all Novanta locations and business contacts of Novanta (less than 20% of working time)

LI-UK1

Ludwigsstadt

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