Quality Engineer
vor 2 Monaten
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 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 key role for the quality and effectiveness on the device when used to treat our patients.
Your daily tasks will be related to ensure 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.
Your key functional responsibilities of this position include
- Lead product and process quality improvement initiatives by reducing quality defects
- Work with non-conformity management process to define product disposition and perform risk evaluations and 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
- Perform and establish data analysis for quality impacting data
- Perform, establish, and drive tests in alignment with experts in R&D and Process Engineering for product qualifications, risk assessment activities or technical investigations
- Act as primary interface between various business functions for product and process improvement initiatives
- Support regulatory audits on site
- Support quality operations in local manufacturing, supply chain and product sustenance to maintain quality compliance
- Responsible to drive CAPA investigation and corrective actions
- Identify and proactively initiate daily work processes improvement activities
- Any other activities and responsibilities as defined by management relevant to the quality engineering function
- The role requires 5% - 25% travel
- A minimum of a bachelor’s degree in electrical/electronic Engineering or similar qualification along with relevant experience in electronic or electro-mechanical products in high regulated industry. Alternatively, experiences in serial production of electronic or electro-mechanical equipment with exposure to electronics assembling can be considered
- Experience in MEDTECH industry under quality function is advantageous
- Good verbal and written communication skills in English and German
- Good understanding of quality engineering principles including root cause analysis techniques with 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
- Regulatory Affairs knowledge is preferable
- Pragmatic and result-oriented: autonomous, detail-oriented, and capable to organize and drive activities in alignment with the expectations of stakeholders
- Good team player: open, honest, and appreciative when communicating among peers and management, show strong interpersonal skills
- Innovative mindset: challenge the status quo pursuing the quality principles
- Capable to have a holistic view on products and processes, and proactively drive improvement discussions
- Show ability to be adaptable, flexible and handle quick changing priorities with a collaborative and relationship building attitude
- Good command of Microsoft Suite tools
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 co-operation 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
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