FSQ Functional Safety & Quality Experts GmbH

&lt;p&gt;&lt;strong&gt;FSQ Experts make innovative technology safer!&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;FSQ Experts GmbH offers medical technology companies precise and pragmatic solutions to overcome know-how or resource bottlenecks in the areas of quality management, regulatory affairs or system engineering.&lt;/p&gt;
&lt;p&gt;Our customers manufacture innovative medical devices where megatrends such as robotics, AI technology and IoT play an important role. With our hands-on support, we promote a systematic approach for mastering complexity. We contribute to the certification of safe medical devices while at the same time, we manifest and expand a quality and safety culture in these companies.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;To expand our team of experts we are looking for a Technical Senior Consultant - Medical Devices (m/f/d)&lt;/strong&gt;&lt;/p&gt;
&lt;h2 id=&quot;tasks&quot;&gt;Tasks&lt;/h2&gt;
&lt;p&gt;&lt;strong&gt;How do you contribute to the FSQ Experts team?&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;You actively support the development of innovative and complex medical devices by consulting and engineering over the entire product lifecycle.&lt;/li&gt;
&lt;li&gt;You use your in-depth knowledge of product development, both in the V-model and in agile frameworks.&lt;/li&gt;
&lt;li&gt;You enable the customer to comply with the standards of the IEC 60601-x series as well as IEC 62304.&lt;/li&gt;
&lt;li&gt;You contribute to the implementation of general safety and performance requirements in accordance with global medical device regulations.&lt;/li&gt;
&lt;li&gt;You will coordinate and review technical documentation.&lt;/li&gt;
&lt;li&gt;You empower the customer&amp;#39;s teams through your activities as a technical advisor, process developer, facilitator or coach.&lt;/li&gt;
&lt;/ul&gt;
&lt;h2 id=&quot;requirements&quot;&gt;Requirements&lt;/h2&gt;
&lt;p&gt;&lt;strong&gt;Required qualifications and technical skills:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Relevant experience in the role of technical consultant&lt;/li&gt;
&lt;li&gt;Many years of involvement in the technical development of medical device products&lt;/li&gt;
&lt;li&gt;Very good knowledge of HW and SW standards for medical devices (e.g. IEC 60601-x series, IEC 62304)&lt;/li&gt;
&lt;li&gt;A risk-oriented mindset (according to ISO 14971) and prior knowledge of regulatory requirements worldwide (e.g. MDR, FDA)&lt;/li&gt;
&lt;li&gt;Familiarity with working environments compliant with ISO 13485 and ISO 9001 quality management system.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;Required soft skills and mindset:&lt;/strong&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Pragmatic, structured, communicative and service-oriented; willing to support and empower different types of customers&lt;/li&gt;
&lt;li&gt;Curious and willing to contribute to expanding FSQ&amp;#39;s knowledge base in areas such as cybersecurity and artificial intelligence&lt;/li&gt;
&lt;li&gt;Self-organized with excellent project and time management skills; able to support different projects in parallel&lt;/li&gt;
&lt;li&gt;Business fluent in German and English (both at least level C1)&lt;/li&gt;
&lt;/ul&gt;
&lt;h2 id=&quot;benefits&quot;&gt;Benefits&lt;/h2&gt;
&lt;ul&gt;
&lt;li&gt;competitive salaries and performance-based bonus&lt;/li&gt;
&lt;li&gt;remote work and home office furnishings&lt;/li&gt;
&lt;li&gt;modern working equipment&lt;/li&gt;
&lt;li&gt;flexible working hours&lt;/li&gt;
&lt;li&gt;a respectful way of working with each other&lt;/li&gt;
&lt;li&gt;an open appreciative way of communicating&lt;/li&gt;
&lt;li&gt;to be part of a motivated team&lt;/li&gt;
&lt;li&gt;a bright, agile and modern company&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;strong&gt;When will we meet?&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;We look forward to receiving your application (CV + motivation letter). Please let us know your earliest possible starting date and your salary expectations.&lt;/p&gt;
&lt;p&gt;If you have any questions, please contact us on &lt;em&gt;+49 (0) 89 588 087 570&lt;/em&gt;. We look forward to getting to know you!&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Join us to make technology safer for humans!&lt;/strong&gt;&lt;/p&gt;
