Quality Engineer to Physio Control/Jolife AB in Lund

Main responsibilities
In the role of Quality Engineer you are the link between Quality, Development, Operations and our suppliers. Your daily work will focus on Purchasing Controls, Design Controls and Production and Process Controls in accordance with ISO 13485, MDD & QSR. You will also assist with the handling of Nonconforming materials, Audit findings and CAPA. As Quality Engineer you will be a part of the quality department and report to the Quality & Regulatory Affairs Manager. You are operating in a dynamic international environment as part of a global company. Corporate language is English. Major duties/responsibilities:



Review and follow up on supplier’s quality assurance activities, e.g. Production and process qualification including validation.
Perform quality audits and coordinate the closure of findings.
Handling ofnonconforming goods and Supplier corrective action.
Quality assurance activities in projects.
Maintenance and continuous improvements of the Jolife Quality Management System.
Maintain regulatory documents library and keep it current.
Perform gap analysis for new or updated regulatory requirements and identify potential gaps in Jolife QMS.



Qualifications
To succeed in the role of Quality Engineer you are a driven and systematic person with a passion for structure, processes and quality. You are a communicative person who can transfer skills and knowledge in an informative and easy digestable way. You are clear in your message and not afraid to question if needed.

Experience from working in the medical device, pharmaceutical, automotive industry or similar, as well as skills in quality auditing, is preferable. Furthermore, you are accustomed to an international environment characterized by high quality demands, regulations and standards. You work independently and take own initiatives. In addition to a university degree in engineering or similar, you have a good understanding of risk management, process development and process validation, and are experienced in working in and/or managing projects. You use English fluently in speech and writing.

About the company
Jolife AB, a wholly owned company by Physio-Control Inc/Stryker Inc, develops and markets the LUCAS ™ Chest Compression System, with related accessories for the global market. LUCAS ™ is a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR). Our vision is a world in which no one dies suddenly as a result of an acute, treatable medical event. And our mission is to make Lifesaving Tools for Lifesaving Teams.

Application
For further information about the position please contact Recruitment Consultant Jörgen Björkman at Technogarden, 0739-80 83 95.