Permobil is a globally leading provider of power wheelchairs, manual wheelchairs and seating and positioning solutions, with a strong dedication to improve the quality of life for its users. The company’s strong portfolio of brands, competitive product offering, innovation capabilities and leading market positions provide a strong base to capture additional growth, both in existing and new markets. Our products are available today in 70 countries across four continents. Our turnover is more than 3 billion, and we have approximately 1600 employees. Since 2013, Permobil is a part of Investor AB.
The Quality Assurance & Regulatory Compliance-department at BU Power Products is expanding and is now searching for a new Quality Assurance Manager.
In this role you will collaborate in a cross functional team together with quotation engineers, mechanical, electronics and software development engineers, product managers and other stakeholders to ensure the quality of our Medical Devices. Your focus area will be our Custom Made Medical Devices. You will be responsible to assure from a QA/RA perspective all steps in the Custom Made process, from receiving a Custom order to delivery, this include (but is not limited to), acceptance of order, development, manufacturing, documentation and release.
As a Quality Assurance Manager, you will assure that process and product compliance is maintained through proper processes within the Quality Management System (QMS) following Medical Device Regulation (MDR).
• Develop, manage and review assigned processes within the QMS, and ensure that they are compliant to all applicable regulatory requirements.
• Review the implementation and efficiency of QMS processes within the organization
• Perform QA review and approval of records from QMS processes where applicable
• Investigate non-conformance issues and CAPA
• Act as CAPA Coordinator
• Collect, compile and analyze quality data (product and process)
• Identify training needs and organize training in applicable processes within the QMS
• Support organization regarding Quality Assurance and Regulator Compliance issues
• Interpret and implement assigned standards and regulations
• Software application responsibility for applicable systems within assigned areas
• Act as internal auditor of our QMS
• Coordinate and support on-site audits conducted by external providers
• Evaluate audit findings and participate in implementing appropriate corrective actions
• Initiate and/or lead projects to improve quality assurance processes
• Monitor risk management activities
You will be a part of a team reporting to the Director of Quality Assurance and Regulatory Compliance, and interact with all parts of the company as well as competent authorities, notified bodies etc. The position in based in Timrå.
You have a university degree in science or engineering. You have working experience, preferably from Med Tech or Pharma industry and/or have good knowledge of quality management systems.
As a person you are a team oriented problem solver with organizing skills and attention to detail. You have great communication skills, which you will use both in investigations and when performing training.
You are fluent in oral and written Swedish and English.
For more information about the position, contact Sofie Petersson, Director QA & RC, 070-9105776
For information about the recruitment process, contact Anna-Karin Ehn, HR Business Partner, 070-3271838
For contact with union representatives, please email: email@example.com
Please submit your application via our career page, no later than 31st of January.
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