Together we can make a difference
At getinge we are dedicated and passionate about helping our customers save lives and ensure excellent careWe provide innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutionsOur portfolio combines well-known product brands such as maquet, pulsion, atrium, lancer and datascope – just to name a few.
A career at getinge will provide career opportunities that both inspire and challengeHere, you can make a difference every day.
The software quality engineer, qms will support the validation activities to confirm that proposed software and network solutions and changes meet the needs of the company and quality before they are promoted into active use“support” can entail anywhere from providing sme guidance on the validation process to business owners, and review of the validation for appropriate compliance – to creating project documentation, leading a cross-functional team for the validation project, writing protocols, and executing protocolsThe needs will vary from project to project.
Who you are:
You are a software-savvy person with a knowledge of networking technologies that is a champion of quality and an advocate of best practices to meet regulatory and compliance needsYour critical thinking skills will constantly be employed to assess whether the approaches used are compliant and appropriate to the business needsYou will use your acute organization skills to manage validation projects and deliverables for you and your project teamYour knowledge, communication and collaborative people skills will be used to provide business and technical translations ensuring transparency of information between the users and the techiesExcellent project documentation skills will be required to record plans, deliverables and statusesFlexible work hours and options are available, however the position is expected to support the business – and therefore would expect the majority of those hours to coincide with those we support.
Job responsibilities and essential duties
Determine activities required for quality management system (qms) software projects.
Generate and review qms software project plans, protocols, reports and test scripts.
Track and guide qms sw project schedules
Support and review engineering changes to qms software.
Perform other duties, as assigned.
Minimum requirements
Bachelor’s degree in engineering or computer science, or equivalent experience.
Minimum of two years related qa experience with medical device quality system software.
Required knowledge, skills and abilities
Great communication and organizational skills.
Excellent documentation skills.
Analytical and problem solving skills combined with technical presence.
Understanding of quality system regulations, iso 13485 and other recognized international quality system and software standards and how they relate to quality practices.
Project management, prioritization and collaboration skills are required.
Microsoft office intermediate user of word, excel and powerpoint.
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
We look forward to receiving your applicationIf you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your applicationWe hope you will join us on our journey to become the world’s most desired medtech company.
