Compliance and Design Quality Engineer

OneProjects is a privately held medical device company based in Dublin (Ireland) and Munich (Germany). The company designs and develops cutting edge innovative imaging technologies to significantly advance healthcare and solve truly global unmet clinical needs. With creativity, passion and focus, we apply our best in class engineering and design knowhow to create new hardware, software and data science technologies. We are currently looking for a Compliance & Quality Engineer to ensure business success’ now and for the future. The Compliancy & Quality Engineer is responsible to setup, manage and maintain the global quality system and processes OneProjects. OneProjects is in an interesting phase as it is currently building its Quality System in compliance with ISO 13485 . The Compliance and Quality Engineer will have a key role in helping the setup of a Quality System and helping OneProjects to get the certification. That represents being involved in E2E Quality, including but not limited to supplier and manufacturing controls, design controls, document controls among others. Additionally, the Compliancy & Quality Engineer is responsible to help setup tests scope and protocols to product compliance with technical standards such as,  but not limited to, the IEC 60601 series. For that we are looking for someone who has had hands-on experience in 60601 testing for at least two , up to 4 years. This role will have also the responsibility to train a junior quality member of the team in this area of product compliance. This person will work hand in hand with R&D in deciding the test scope and writing test protocols for showing product compliance with the technical standard. This person will with time be responsible for all product technical standards compliance, that include among others biocompatibility, sterilization, mechanical, cybersecurity, among others. All of this is based on and in alignment with the strategic pillars (Safety, Flexibility, Business Alignment , Wellbeing and Sustainability. The Compliancy & Quality Engineer is a member of the Quality & Regulatory team and part of a matrix organization and therefore is both responsible for managing the company processes as well supporting  other teams by establishing standards, guidelines and best-practices. If you are looking to develop yourself in all areas of Quality and product compliance and want to be part of an  agile and independent team with lots of room for grow,  we are looking for you!

YOUR ROLE WITH US

  • Create a vision on and take ownership to achieve a worldwide standard level of quality and compliance for OneProjects.
  • Develop the quality monitoring system in order to structurally work on and comply to internal guidelines and market regulation, policies and guidelines that are applicable to our company and products (f.e. compliance to IEC 60601, ISO 13485 ISO 10070 , etc.).
  • Manage the process of compliance monitoring, compliance reviews and auditing, – Responsible to deliver and manage a consistent set of methods and instruments, documented, up-to-date and compliant with regulations and policies.
  • Execute audits or internal reviews and, based on compliance reviews, give advice about appropriate steps to improve or solve compliancy risks consistent with regulations, rules and policies.
  • Support both the global and local organizations in the execution of compliancy reviews. And by determining and/or give advice about areas in which quality management could be further developed and how to set up the processes to do so.
  • Manage the roadmap for compliance reviews and further implementation/roll out of the quality system.
  • Plan, drive and support the implementation of new or changed instruments or act from a quality assurance role in implementation projects.
  • Maintain the process framework and streamline the applicable methods/protocols used in the field.
  • Streamline standards and processes to establish a uniform approach and ensure an appropriate document management system and change control process.
  • Roll out/implement the various methods for quality management at our two sites or support local teams with implementing and meeting the standards.
  • Contribute to reporting processes and establish the registering system for documents and evidence of compliance.
  • Act as the liaison to ensure compliancy to corporate methods, reporting and accountability processes of the Dublin office
  • Manage and maintain the overall central document management system for OneProjects Quality System and Product Compliance.

WHAT YOU OFFER

  • BSc/MSc in Engineering, preferable in electrical , but can be other.
  • 1 to 3 years of relevant work experience.
  • Experienced in implementing quality management systems with Medical Devices.
  • At least 1 year hands on performing IEC 60601 tests

YOUR SKILLS

  • Ensures accountability
  • Thinks and plans ahead
  • Independent judgement
  • Quality oriented / optimizes work processes
  • Communicative and advisory skills
  • Stakeholders management / relationship management (establishing effective networks)
  • Ownership
  • Organization sensitivity
  • Manages complexity
  • Strategic mindset
  • Analytical and problem analysis/problem solving
  • Flexible and stress-resistance

WHAT WE OFFER

  • Working on cutting edge imaging systems to the direct benefit of patients and improving healthcare.
  • Becoming part of a dynamic, multi-national team of highly skilled individuals with a very strong focus on team culture and individual development.
  • A learning environment where you can extend and build upon your skills and interests.
  • Connecting you with a network of companies and innovators in the technical, clinical and business world from around the globe.
  • A permanent contract with an attractive compensation in an award-winning start-up.
  • Flexible working environment and an international culture as well as offices in Germany and Ireland.
  • Ergonomic workplace in an attractive office – easily reachable by public transport.

OneProjects is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, disability, religion/belief, sexual orientation, or age. Would you like to become part of our team? We would love to hear from you and look forward to receiving your CV and cover letter.

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