Your new role For its Quality Assurance department in Munich, Germany, LivaNova is looking for a new innovative, ambitious talent. We are currently hiring for a SeniorQuality Engineer (m/f/d) to expand and support the advancement of our product portfolio. You will be a key contributor to the quality strategy for our Cardiopulmonary equipment development and manufacturing processes, being key role for the quality and effectiveness on the device when used to treat our patients. Your daily tasks will be related to ensure quality as well as compliance of manufacturing processes and sustaining R&D activities within dedicated projects. Furthermore, supporting continuous improvement of products and processes, you will ensure that we meet our superior mission which is “patients first”. You will support Product Development, Clinical, Manufacturing, and other Quality System activities - locally and globally. Your key functional responsibilities of this position include - Define the requirements for the Design control and design transfer, verification and validation testing, production line testing, and risk management process for new generation devices as well as life cycle management of current devices - Review product and QMS changes for completeness, accuracy and safety/effectiveness including the identification of all impacts - Investigate situation of non-conforming products and define product disposition - Perform and establish data analysis to monitor non-conformities as well as trends and based on this, leads non-conforming product handling process in terms of problem analysis, risk assessment as well to lead related investigations and corrective actions - Perform, establish and and drive tests in alignment with experts in R&D and Process Engineering to perform testing for such as qualifications, risk assessments or technical investigations - Act as primary interface between local manufacturing and Supplier Quality Engineering pertaining to external suppliers‘ activities - Support regulatory audits on site What are we looking for To successfully execute the responsibilities outlined above, your current skillset should include: - A minimum of a Bachelor’s degree in Electrical/Electronics Engineering or similar qualification along with relevant experience in electronic or electro-mechanical products in high regulated industry. Alternatively, experiences in serial production of electronic or electro-mechanical equipment with exposure to electronics assembling can be considered. - Good verbal and written communication skills in English and German - Good understanding of quality engineering principles including, as root cause analysis techniques with ability to show sounds engineering skills/knowledge - Good understanding of basics of statistical tools and risk management techniques - Problem Solver: Demonstrated ability to solve problems, in a organized & structured approach. Lean & Six-Sigma skills are advantageous - Knowledge is use of statistical application tools e.g., Minitab - Regulatory Affairs knowledge is preferable - Pragmatic and result-oriented: autonomous, detail-oriented and capable to organize and drive activities in alignment with the expectations of stakeholders - Good team player: open, honest and appreciative when communicating among peers and management, show strong interpersonal skills - Innovative mindset: challenge the status quo pursuing the quality principles - Very good command of Microsoft Suite tools What we can offer you In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following: - A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth - Exposure to a State-of-the-Art medical device development process, in close co-operation with international clinicians - Competitive base salary
Senior Quality Engineer (m/f/d) (Ingenieur/in - Elektrotechnik)Senior Quality Engineer (m/f/d) (Ingenieur/in - Elektrotechnik)