Quality Assurance (QA) Engineer

When you can´t breathe, nothing else matters. That’s why a career at Breas Medical matters.

Our mission is to improve the quality of life and care of respiratory patients around the world through a personal commitment to innovation, quality, and customer focus.

Are you our next Quality Assurance (QA) Engineer in Mölnlycke?

Are you a detail-oriented dynamo with a passion for digital efficiency and a commitment to help the team do the right thing? Are you eagerly curious about opportunities to develop your quality assurance expertise within a growing medical device company? Then this role may be tailored for you.

As QA Engineer at Breas Medical, your main goal will be to maintain an effective digital Quality Management System (QMS) that supports our business processes and meets MDSAP, ISO 13485 and other regulatory requirements, to improve the QMS to meet new or changed requirements and business needs, and to make it more efficient to use. You will be the admin for our QMS applications, support and train users, and develop our Document Control process.

In this role you will also work with evaluation and reporting of complaints and vigilance events, Field Safety Corrective Actions (FSCA) and recalls, and master plans and programs for calibration and validation. You will also be part of the team that prepares and hosts external regulatory audits.

As you will work with both international and local personnel, both spoken and written English and Swedish for professional use are a must. On-site presence in the Mölnlycke facility is required.

Main responsibilities

• Maintain the QMS applications for document and change control, complaints and nonconformities, including:
• Support and train users of the QMS applications.
• Administration of the QMS applications.
• Maintain and support with forms, templates and documentation standards. 
• Coordination with IT service providers and application vendors for change and support requests.
• Implement and maintain Document Control including:
• Prepare, review, approve and publish documents as per document approval matrix.
• Monitor the queue of new documents to be published.
• Monitor status of document control and escalate deficiencies or noncompliance.
• Monitor, evaluate, coordinate and report complaints and potential adverse events/serious incidents, including:
• Monitor and evaluate complaints for potentially reportable events/incidents.
• Support with and follow up complaint investigations related to reportable events/incidents.
• Prepare and submit reports of adverse events/serious incidents to regulatory authorities and monitor their status.
• Support and perform material and product inspections and approve corresponding Certificates of Conformity and similar release documents as needed.
• Coordinate and support with Concessions, Product Holds, Field Safety Corrective Actions and Recalls as and when needed.
• Monitor and support the calibration and software validation programs to secure compliance. Coordinate and perform re-calibrations and re-evaluations as needed.
• Support with preparations and hosting of external audits. Prepare and conduct assigned internal audits.
• Act as QA representative for assigned projects and initiatives.
• Work closely with process owners and subject matter experts, to support with nonconformity and CAPA investigations and actions, as well as other quality assurance matters.
• Stay aware of and comply with the Quality Management System, Quality Policy, Quality Goals, and applicable laws and regulations. Maintain up-to-date knowledge and understanding of current quality assurance requirements within area of responsibility.
• Identify and report critical quality or compliance concerns to management and take immediate corrective action as required.

To be successful in this job, we believe that you possess the following requirements and skills.

• Education: Secondary education, college or academic degree in information technology, science, medical, engineering or other relevant field.
• Experience: At least 3 years’ relevant experience from application development, support, QA/QC, testing or documentation processes, and/or medical device manufacturing and inspection.
• Language: Good command of English and Swedish for professional use, both in writing and verbally. Additional languages such as Mandarin, German or Spanish are a plus.
• Attention to Detail: As your work deals with patient safety, quality and regulatory compliance, attention to detail is critical. You are aware that omissions and errors can lead to serious problems, and enjoy analyzing and reviewing data to identify potential issues.
• Efficiency Mindset: In addition to strong attention to detail, you like to be efficient as you manage multiple tasks and requests. The ability to focus on the most important and keep track of deadlines is key to keep business running and ensure timely responses to regulatory authorities. You are organized and can work independently to complete your tasks, and follow up that you get what you need to finish the job.
• Digital Aptitude: You have strong technical proficiency and will comfortably master administration and use of the QMS applications. Proficiency with digital tools and an ability to leverage technology to automate routine processes will be very useful in this role.
• Reliable Helper: Collaboration is crucial for working with users, process owners, and IT application vendors. You are able to build positive relationships within the organization, enjoy answering questions and are a person that others can depend on to provide support.

To apply, please submit your CV, cover letter, and any other relevant materials. We look forward to hearing from you.

Please note that we work with continuous recruitment. 

More About Us

Breas Medical is a global company headquartered in Sweden, with over 30 years of expertise in ventilation, airway clearance and sleep solutions. We are passionate experts dedicated to respiratory care, with unwavering focus on the patient and the caregiver, delivering high quality and reliable products. We respond to your changing needs with agility, and while growing globally, we take customer care personally. Our solutions cover a broad range of devices, consumables, service solutions, educational & training programs, and comprehensive connectivity capabilities to improve the quality of life of patients, from hospital to home.

Breas Medical employs over 300 people globally. Our solutions reach 50 counties around the world, and we manufacture our product in four countries, China, UK, Sweden, and the US.

Find out more about Breas:
educationbybreas.com
breas.com

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