When you can´t breathe, nothing else matters.
Our vision at Breas is to provide innovative solutions that enable people with chronic respiratory conditions to live life to the fullest.
We are looking for a Quality Assurance (QA) Coordinator who wants to make an impact and change the world of ventilation for the better.
At Breas Medical, you will get the chance to work on projects of high importance that improve our users’ quality of life. Working at Breas Medical will most likely be a new, impactful chapter of your life, and be a great opportunity for personal growth.
You will be joining Breas at a very exciting stage of our journey. We have just launched two new product series within our Vivo range, with a total of seven new ventilator products. These new products enable us in our strive to be our customers preferred choice and the global market leader within the mechanical ventilator product segment.
This position is within our Global QA&RA department based at the Breas global headquarters in Mölnlycke, Sweden. Breas Medical is owned by the Chinese healthcare group Fosun Pharmaceutical (Group) Co., Ltd. that is traded on the Hong Kong stock exchange.
We are looking for a
Quality Assurance (QA) Coordinator
Key responsibilities and tasks
As a QA Coordinator, you will join Breas Medical's global QA&RA team with members in Sweden, UK, US and China. You will work closely with colleagues from all functions to coordinate and support with QA activities required for product safety, quality and regulatory compliance.
Your main focus is to maintain and improve the global Quality Management System (QMS), and to provide training and support in the QMS software. Reviewing, approving and publishing documents in accordance with the document approval matrix will be a daily activity.
You will support with monitoring of complaints and investigation of potential adverse events, and coordinate and support with Product Holds, Field Safety Corrective Actions and Recalls when needed.
You will also work with Operations with quality assurance of material and products, supporting with inspections and release, Certificates of Conformity and similar.
When nonconformities and urgent quality issues are found, you will support with investigations and coordination.
In this role, you will act as QA representative for assigned projects and initiatives.
You will work closely with process owners and subject matter experts, to support with nonconformity and CAPA investigations and actions, as well as other QA matters.
We are certified to MDSAP, ISO 13845 and MDD/MDR, and you will be part of the core team to prepare, coordinate and host the annual audits, as well as unannounced audits.
Experience you will bring
- You are very organized and can work independently, and keep track of and coordinate many concurrent activities.
- You have a hands-on, can-do attitude that will fit well with our informal, entrepreneurial and friendly culture. You get things done and learn quickly.
- You appreciate correct, well structured documentation and are an efficient reviewer.
- You enjoy improving systems and supporting and training people in your areas of expertise.
- Formal qualifications include an academic degree in science, medical, engineering or other relevant field plus relevant experience from organizing, preparing and reviewing structured documentation.
- Education and/or experience within Quality Management Systems and Quality Assurance is a strong plus.
More About Us
Our focus is first and foremost on the patients and customers we serve. Breas Medical was founded in 1991 in Gothenburg, Sweden, and has become one of the global leaders in Home Mechanical Ventilation, Airway Clearance and Sleep therapy. Our vision is to provide better breathing and quality of life to respiratory patients around the world and to help patients transition from Hospital to Home.
Breas is headquartered in Sweden and has subsidiaries in the UK, Germany, Spain, USA and China. Breas has approximately 250 employees. Together with a network of highly specialized distributors, we serve over 40 countries worldwide. The Breas brands Vivo, Nippy, Clearway and Z1 are widely recognized and appreciated for their performance, design and ease of use.
We highly value our relationships, never compromise on quality, continuously improve customer support and expand our clinical excellence program that consists of study days, webinars, educational videos, symposia and clinical research. We work closely together with key opinion leaders around the world to stay updated on the latest clinical insights. All Breas products are designed to fulfil our vision and to help patients transition from Hospital to Home. We strive to become a total solution provider offering a broad range of products, from smart CPAPs to Bi-levels, NIV ventilators, Life-Support ventilators and Airway Clearance devices. Add to that a growing range of accessories and remote connectivity solutions.
Find out more about Breas:
breas.com or check out our channel on Twitter, LinkedIn or Facebook.
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