Job Description

With a passion for life
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.

Skills Required