Quality Engineer

Quality Engineer

LivaNova

Munich, Germany

 

We are currently hiring for a Quality Engineer (m/f/d) to expand and support the advancement of our product portfolio. Your daily tasks will be related to ensuring quality and compliance of manufacturing processes and sustaining R&D activities within dedicated projects. Furthermore, you will contribute to continuous improvement of products and processes, ensuring that we meet our superior mission which is “patients first”.

Within a multicultural team of 7, you will report directly to the Quality Engineering Team Lead, 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 leadership and direction.
  • Responsible for the risk management file, compliance with design control regulation, the completeness and sufficiency of design verification and validation activities, and manufacturing quality and validation planning.
  • Responsible to guide the team in design transfer activities including to work with manufacturing team to strategize efficient & effective validation approaches for manufacturing processes and test methods (e.g. Process Validation & Test Method Validation).
  • Reviews product and QMS changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts.
  • Identifies which complaints, non-conformities and trends warrant investigation via the CAPA process. Initiates and leads investigations and corrective actions as required.
  • 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.
  • Generates, maintains and updates risk management documentation throughout the life cycle of a product.
  • Contributes to successful regulatory audits by coordinating back room/front room activities or serving as a subject matter expert.

What are we looking for?

  • A minimum of a Bachelor’s degree in Electrical/Medical/Mechatronics Engineering or similar along with minimum of 3 years work relevant experience in above described areas and functional responsibilities gained in a regulated environment industry, preferably with a medical device manufacturer
  • Advanced verbal and written communication skills in English and German
  • Understanding of basic quality engineering principles including, but not limited to quality leadership, implementation, statistical techniques, 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
  • Is detail-oriented but keeps an overview among several topics and their prioritization at the same time
  • Strong interpersonal skills and innovative mindset

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© EuroJobsites 2021

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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