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We are looking for an ambitious and enthusiastic colleague to our Product Assurance group which is a part of QA. Product Assurance focus on implementation and maintenance of new and existing products/processes, which includes sustaining engineering (change control), process validations and complaint handling.
You are proactive, analytical and structured and have an ability to manage multiple projects simultaneously. As a Product Assurance Engineer with a sense for details you will contribute among other things to assure that the implementation and changes of new and existing products and processes are tested and documented in a quality assured manner. By being flexible in case there are needs within the group you will contribute to achieve the set goals of the company in order to serve our final users with high quality products on time.
Main job responsibilities
• Manage and coordinate changes of existing products and processes according to current standards and procedures
• Identify needs for validations/verifications in new and existing products/production processes, plan, test and report these in cooperation with the production and development department
• Manage and coordinate complaint investigations and reports
• Actively identify and drive improvements in products, production and quality processes
• Identify and update relevant product documentation
• Generate and update engineering drawings in Solid Works
Your qualifications & competencies
• Bachelor of Science degree or similar background through experience
• Knowledge of ISO 13485, MDR, GAMP, MiniTab and SAP is an advantage
• Experience of Project management, Change control, Process validations, Complaints within a regulated business
• Proficient in MS Office & Solid Works
• Swedish and English need to be spoken and written fluently
• Experience from medical device is an advantage, however, commitment and enthusiasm are more important
• You are a team player, we succeed and fail as a team
Location and contact person:
This position is fulltime and located in Hörby, Sweden, only 25 minutes from Lund.
Please submit your application in English or Swedish to us as soon as possible - we will continuously look for potential candidates. Last application date August 12.
If you have questions regarding this position, you are welcome to contact Lizelotte Falk, Product Assurance Manager via email firstname.lastname@example.org or call +46 (0)415 16938
Product development, Production and QA/RA are under the same roof which is highly appreciated and a real advantage in the quality assurance process. You will be part of an ambitious and engaged work environment where great results are continuously delivered. At Atos Medical you will have great opportunities to help users with getting their voice back and to continuously learn and develop your potential.
Join us and give people a voice
We are a fast growing, market leading medical device company with a purpose. Our field is voice and lung rehabilitation for cancer patients who have had their voice box removed, and consequently lost the ability to speak and breathe in the same way as they did before. We design, manufacture and sell our product portfolio directly to patients, as well as to leading medical institutions and health care professionals. We currently have more than more than 20 subsidiaries and employ nearly 800 people worldwide.
We are committed to living our values: We listen – We focus – We engage – We inspire every day. We connect with all our stakeholders, involve them in our activities and strive to support and empower our users every day. We design solutions and technologies built on decades of experience and a deep understanding of our users.
We are constantly looking for new employees who are passionate about the direct interaction with our customers, who search for stretched assignments to develop and who want to create results in one of our great teams. The last two years we have attracted and onboarded 400 new employees globally, and we are proud of our unique purpose, the development opportunities and the way we work.