Quality Engineer (m/f/d)

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Quality Engineer (m/f/d)

Position Summary

For its Quality Engineering department in Munich, Germany, LivaNova is looking for a new innovative, ambitious talent. We are currently hiring for a Quality Engineer (Junior or Level I) to expand and support the advancement of our product portfolio.

You will be a key contributor to the quality strategy for our Cardiopulmonary equipment development and manufacturing processes, being a key role for the quality and effectiveness of the device when used to treat our patients.

Your daily tasks will involve ensuring quality as well as compliance of manufacturing processes and sustaining R&D activities within dedicated projects. Furthermore, supporting continuous improvement of products and processes, you will ensure that we meet our superior mission which is “patients first”.

You will support Product Development, Clinical, Manufacturing, and other Quality System activities - locally and globally.

General Responsibilities

• Support and drive product and process quality improvement initiatives by coordinating with cross-functional experts for reducing quality defects.
• Support quality operations in local manufacturing, supply chain, and product sustenance to maintain quality compliance.
• Independently drive non-conformity report activities including but not limited to conducting risk assessments, investigating root cause, and implementing corrective actions.
• Collaborate as main stakeholder to define the requirements for design control and design transfer, verification and validation testing, production line testing, and process risk assessment for new generation devices and life cycle management of current devices.
• Review product and QMS changes for completeness, accuracy, and safety/effectiveness.
• Support regulatory audits on site.
• Perform Quality control (QC) of all products based on established processes.
• Perform DHR management and control of all products according to established process and work instructions.
• Identify and implement process improvement solutions for DHR document management, data entry traceability, and document retrieval, including conducting solution effectiveness checks.
• Any other activities and responsibilities as defined by management relevant to the quality engineering function.

Skills and Experience

• A minimum of bachelor’s degree in engineering with technical specialization, preferably in Electronics or Mechatronics. Alternatively, relevant technical job experience in a suitable job area.
• A few years’ experience in relation to the described job function would be preferred, and a university degree is advantageous.
• Strong interest in medical devices.

• Good verbal and written communication skills in English and German.
• Good understanding of quality engineering principles including root cause analysis techniques with the ability to show sound engineering skills/knowledge.
• Good understanding of basics of statistical tools e.g., Minitab.
• Experience in performing risk management techniques/assessments.
• Problem Solver: Demonstrated ability to solve problems in an organized and structured approach.
• Lean & Six-Sigma skills are advantageous.
• Pragmatic and result-oriented: Detail-oriented, and capable of organizing and driving activities in alignment with the expectations of stakeholders.
• Good team player: open, honest, and appreciative when communicating among peers and management, showing strong interpersonal skills.
• Ability to be adaptable, flexible, and handle quickly changing priorities with a collaborative and relationship-building attitude.
• Good command of Microsoft Suite tools.
• Quality Engineering knowledge is a plus.

What we can offer you

In addition to providing you with a supportive, inclusive, and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:

• A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth.
• Exposure to a State-of-the-Art medical device development process, in close cooperation with international clinicians.
• Competitive base salary.
• Variable short-term & long-term incentives.

• Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements.

If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!

Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent, and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race, or any other legally protected classification.