Software Validation Engineer
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Belleville, IL 62221
Permobil is a global leader in Advanced Rehab Technology and owned by Investor AB. We are present in more than 70 countries with 1 600 employees and have an annual turnover of more than SEK 3 billion. Our major brands are Permobil, TiLite and ROHO, with more to come. For 50 years, we have used technology and innovation to improve the daily lives of people with disabilities. This focus on innovation for the benefit of our users have enabled the company to grow consistently and profitably. We are looking to continue growing by entering new geographical markets and adding new technologies and products, to further support the community of people with disabilities. Software validation engineer Global IT within Permobil is looking for someone who can lead us in the field of Quality assurance and in particular Software validation within our medical regulated operation. Permobil invests in the highest quality of our products and customer support. We are now looking for a new co-worker within IT Solution management. We offer our employees a modern, friendly, international environment. We encourage them to innovate and grow. We are in the middle of an exciting journey to renew our IT system landscape that will support our entire global business. One of the challenges in this transition is to uphold quality and regulatory demands in the IT services we provide. In that area it is essential that software validation gets done in a proper way. You will work together with the rest of the team stationed in Sweden and the United States. The team consists of IT architects, application developers, project managers and business analysts. You will be leading the overall work regarding software validation together with two resources within the team. Would you like to work for a company who leads the way in Advanced Rehab Technology? Are you looking for an international position with the possibility to make a difference for people who really needs it? Then we suggest you continue reading. YOUR ROLE – Key responsibilities The software validation engineer maintains software validation policies and procedures, leads validation projects ensuring compliance with global regulations and company standards while ensuring that company processes and products meet specifications and standards. You will report to the Director of IT Solution management and will perform duties related to software implementation and validation including deviation management and change control. In order to be successful, you must abide by corporate policies and industry best practices. In the journey to implement our new IT landscape, you will have a leading role in system validation, and you will have two consultants to assist you. The roll-out of the new IT landscape will be launched in a first phase in the spring of next year and will proceed in the next few years until all Permobil’s operations are integrated. YOUR PROFILE – Qualifications We are looking for someone with experience in quality assurance of IT systems supporting life sciences organizations regulated by, among others, the European Union and the US FDA. You have worked in organizations that are compliant to standards such as ISO 13485, or ISO 9001. You have experience validating applications compliant to FDA 21 CFR part 11. You also possess knowledge of guidelines such as the FDA “General Principles of Software Validation” and GAMP 5. You can identify a vision along with the plans which need to be implemented to meet the end goal, evaluating situations, decisions and issues in the short, medium and long term. To provide the best value you share knowledge and resources across Permobil, look for value for the business, set plans and manage them effectively. You also consider the business implications in your decisions, avoid waste and challenge the use of resources and processes to maximize effectiveness. As a person, you are innovative and have a structured way of working with leadership qualities that drive the area of software validation forward. You have the ability to lead and communicate with other people as well as give a confident impression. You are also curious and have an interest in IT technology. The position will be located on-site in Belleville, Illinois and will include travel to some extent. Possibility of telecommuting one to two days per week. Relocation assistance available. You also have experience in: • Validating COTS, on premise and cloud hosted systems • Performing concurrent and retrospective validations • You have experience from the IT industry in a similar role • Leading projects or activities involving other people • Degree from university in relevant area or other comparable experience • You master English in speech and writing It is desirable if you: • Have experience working within IT quality in the medical device industry • Are familiar with the following standards and regulations: ISO/TR 80002-2, 21 CFR Part 820, Medical Device Directives (MDD) such as EU 93/42/EEC