Complaint Specialist
Location: NetherlandsThe Company
Being one of the most innovative companies in the healthcare industry with over 400 exciting and groundbreaking products designed to improve the quality of life of all of it's customers. Operating both B2B and B2C, their influences on the healthcare sector as a whole have been immense in it's 100+ years of operations.
Role Description
As a compliance specialist you evaluate and resolve complaints, initiate CAPAs, analyze complaint data, other additional data as needed. Provide feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations
Responsibilities
· Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally
· Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint.
· Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint.
· Assess if the Risk assessment is covering the hazard in the complaint
Requirements
· Bachelor degree in bio medical, engineering, healthcare, nursing or related technical degree with 4 - 8 years of experience; OR Bachelor degree with 4+ years of experience in a medical device or regulated industry.
· Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
· Fluent in English, both verbal and in writing
· speaking Dutch is mandatory
For more information please contact Michaël Rodrigues at m.rodrigues@sire-search.com or +31 (0) 206589800 or click the button below
