Quality Engineer

Quality Engineer

LivaNova

Munich, Germany

About the Role

For its Quality Assurance department in Munich, Germany, LivaNova is looking for a new innovative, ambitious talent. We are currently hiring for a (Junior) Quality Engineer (m/f/d) to expand and support the advancement of our product portfolio. Due to a significant investment into our R&D activities your daily tasks will be related to innovating next-generation products such as our market leading heart-lung-machine. Within a multicultural team of 7, you will report directly to the Senior Manager of Quality Engineering, and will support Product Development, Clinical, Manufacturing, and other Quality System activities - locally and globally.

Role Responsibilities

  • Serves as a core team member on product development teams by providing technical support and direction
  • Responsible for the risk management file, compliance with design control regulation, the completeness and sufficiency of verification and validation activities, and manufacturing quality and validation planning
  • Reviews product and QMS changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts
  • Identifies which complaints and trends warrant investigation via the CAPA process and initiates CAPA investigations as required
  • Identifies and initiates product and labelling improvements based on complaint and trending data
  • Lead (technical expert) and oversee/approve investigations of manufacturing nonconformities, audit nonconformities and CAPAs to identify root cause and corrective actions in a timely and compliant manner
  • Collaborates with Operations to define and implement systems that enhance efficiency, productivity and quality
  • Provides quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for validation activities
  • Ensures that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes and global QMS processes

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 Engineering (alternatively Mechanical, Biomedical or Software Engineering) along with 3-5 years work experience gained in a regulated environment industry, preferably with a medical device manufacturer
  • For JUNIOR profiles, that have recently graduated, a Master’s degree in Electrical Engineering (or specialization such as thesis in electrical equipment) is mandatory and in addition industry (preferably medical devices) related internships throughout their studies
  • Fluent verbal and written communication skills in German and English
  • Understanding of basic quality engineering principles including, but not limited to quality leadership, implementation, acceptance sampling, statistical process control, lean business systems and other continuous improvement techniques, and risk management
  • Pragmatic and result-oriented: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders
  • Good team player: open, honest and appreciative when communicating among peers and management
  • Resolves most issues with peers, but understands what issues are important to escalate to management
  • Strong interpersonal skills and innovative mindset

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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