Technical Writer MedTech

We are looking for a Technical Writer who has experience in writing IT documentation and will be responsible for supporting a full range of validation activities.

Tasks and Responsibilities:
• Produce high-quality GxP documentation that meets applicable standards and is appropriate for its intended audience
• Proven project-based work experience under GxP guidelines and possess a strong knowledge of those requirements & documentation practices
• Developing technical documentation to guide future software development projects
• Develop technical documentation to support application maintenance.
• Creating Software test specification IQ/OQ/PQ and Application/Validation Qualification Final Report.
• Creating and performing functional and quality risk assessments
• Create educational and training materials
• Develop documentation materials to support the administration and configuration of our products
• Execute Hardware and Software Installation qualifications
• Establish a close collaboration with the software development, product management and customer-oriented to strengthen produced documentation materials
• Produce high-quality documentation for IT infrastructure processes, procedures, and technical solutions (documents, drawings, slides, etc.)
• Meeting with engineers, programmers, and project managers to learn about specific products or processes.
• Generating Requirement Specification Documents - URS, FS, DS, TS, CS in accordance with GXP regulations.


Your Profile:
• Work experience in the MedTech industry is desirable but not a prerequisite.
• Proven knowledge of software systems, frameworks and tools in embedded Software development and Software Toolchain
• Deep understanding of Software Architecture
• Knowledge and solid experience in Software and App development.
• Ability to create, update and maintain GxP documentation including but not limited to: technical manuals and specifications, instructional material, training manual, user manual, diagrams, process flows, step by step instructions, policies and procedures, test plan and report, and product documentation for internal and external audiences.
• Knowledge of/work experience in cGMP environment and familiarity with Technical Change Control is highly desirable.
• Experience in Software as a Medical Device SaMD is an advantage.
• Familiarity with maintenance processes and documentation, such as work orders, operating procedures and work instructions.
• Familiarity with Agile development technologies is desirable.
• Ability to work as part of a team or individually on a project.
• Ability to interpret Quality standards for implementation.
• Ability to independently evaluate situations and propose potential solutions.
• Ability to communicate clearly and professionally both verbally and in writing.
• Ability to manage multitask and prioritize assignments to meet assigned deadlines.
• Knowledge of Software solutions such as Azure DevOps, GIT, Microsoft Office, PowerShell
• Ability to independently gather information from subject matter experts to develop, organize and write design documents, technical drawings, product specifications, user acceptance testing, procedure manuals, technical specifications, and process documentation.
• Fluency in English (C1 level minimum), a good command of German is a plus – certificate needed.
• Along with your CV, please also send us samples of your work / projects history.

• Company bonus (based on company financial results)
• Referral bonus depending on level of person referred
• Business mobile (also for private calls) and laptop
• Heath-/Dentalcare costs coverage (up to 250EUR/year)
• Allowance for foreign languages classes/sport and leisure activities (up to 200EUR/year)
• 3 sick days per calendar year
• 2 extra days off for your wedding
• Social events (team-buildings and team-dinners)
• Budget for trainings & certifications
• Monthly events in Kosice (Office)
• Home Office upon agreement (or possibility to work from our office in Kosice)
• Flexible working hours
• Become part of an established company with a start-up mindset (Self-organizing, flat hierarchy)
• Ice Hockey tickets discount (HC Kosice home games)
• 7 compensated days for training purposes

Please submit your application in English.
Thank you for applying to Arcondis!