Risk Management Specialist

HemoCue, sedan april 2013 en del av Radiometer Group, är ett världsledande företag inom patientnära testning. HemoCue AB, beläget i Ängelholm, introducerade 1982 det första patientnära hemoglobintestet. Företaget säljer även patientnära tester för glukos, urinalbumin, HbA1c, totala antalet vita blodkroppar (B-LPK) och 5-partsdiff. Besök vår hemsida för mer information hemocue.com

Our Quality Assurance department needs reinforcement; therefore we are looking for a

Risk Management Specialist

The Quality Assurance group is part of the RA/QA department and responsible for quality assurance and quality development activities within the core processes Supply Chain Management and Product Lifecycle Management. This includes QA expertise during product development, production and also further development of the already released products and manufacturing processes, handling of non-conformities as well as the qualification and maintenance of suppliers.

The Job

To become successful, you must cooperate cross-functionally with other departments to develop, implement, and maintain an efficient Risk Management Process. Your responsibilities and tasks will include:

Establishment and maintenance of a Risk Management process for HemoCue products and manufacturing processes that comply with applicable regulations and guidelines Monitoring regulations and guidelines related to Risk Management to ensure compliance To develop and provide training to the organization in Risk Management process and in Risk Management tools Act as Risk Leader in risk assessments and support the organization in risk assessments of products and manufacturing processes Ensure that Health Hazard Criteria is established for each HemoCue system Ensure that risk management files are in compliance with applicable regulations Review and approve documentation related to Engineering Change Orders.


Qualifications
You have a University degree in science or technology (Master or Bachelor)

Experience from the following areas is required:

Minimum three years of experience from Medical Device Industry Minimum three years of experience in Risk Management Knowledge and trained in risk management for medical devices, ISO 14971 Knowledge in ISO 13485 and QSR Good knowledge of Swedish and English in speech and writing are essential
Personality
As a person you are conscientious, attentive to detail and inquisitive. You are a team player, efficient, structured and solution-oriented and who likes a fast pace. You find it easy to communicate with other people and enjoy working in a company that is driven by continuous improvement, both in terms of equipment and processes.

Interviews will be held as soon as relevant candidates have been identified

Send your application via www.hemocue.com/jobbsidan . We are not able to receive your application by other means than through “jobbsidan“. Please bring diplomas for face-to-face interviews. Any application by mail or e-mail will be returned.

We offer you

A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Sweden and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. Also we offer you opportunities for training and career development.

We are looking forward to receiving your application.

For further information, please contact Quality Assurance Manager, Anna Stegmark at tel. +46 734 14 05 50.

Union information is available from Patrik Heimby, Unionen, +46 431-48 14 10 or Lars Bergman, Akademikerföreningen, +46 431-48 15 60.