Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Purpose:
The QRC Administrator is responsible for supporting the SSU QRC Team in maintaining the Quality Management System and identifying opportunities for improvement.
Key duties and responsibilities:
Field Actions (80%) Support the SSU with the implementation of the Field Action from initiation to closure
Receive, communicate, monitor and close the Field Actions within the given timeframe
Prepare KPIs related to Field Action progress
Communicate with relevant stakeholders within the SSU and wider QRC organisation
Prepare communication for submission to authorities
Nonconformances (10%) Support the SSU by logging NCs received from other departments and sending to the owner
Supporting QRC Specialist and Director with creation of KPIs related to NCs
Support the SSU with the non-product complaints, identification, logging and monitoring
KPIs (5%) Assist the QRC Director with the preparation of the monthly KPIs
QMS (5%) Assist in creating and updating procedures and work instructions
Assist in any QMS project as required
Quality System Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Knowledge/Skills/Experience:
Each organization shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed and shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
Experience in an administration, customer service or similar role
Knowledge of ISO 13485 and/or ISO 9001
Experience using Microsoft Office
Previous experience of working within a medical device environment desirable
Experience using QMS software / SAP desirable
Personal qualities:
Excellent organizational skills and strong attention to detail
The ability to work independently and as part of a team
Strong sense of integrity and confidentiality
Good sense of resilience
The ability to communicate with a wide variety of stakeholders
Permissions/ Authorities:
Each organization shall establish the appropriate authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
Performing QRC tasks as outlined in the applicable SOPs
Communication of FSCAs to affected customers
Assigning of NCs to owners
Assigning of Non-Product Customer complaints to owners
Disclaimer:
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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