Quality Engineer (m/f/d)

Beruf: Ingenieur/in - Biotechnologie

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 (m/w/d) 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 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".

General 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 verification and validation activities, and manufacturing quality and validation planning
• Lead & collaborate including work estimation & planning appropriately to implement projects and activities examples engineering changes, new products, other projects etc.
• Reviews product, process and QMS changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts
• Acts as business process owner of the nonconformance report (NCR) management system, including material review board (MRB) activities, monitoring the timeliness and effectiveness of the system and activities
• 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
• Monitors the effectiveness of corrective actions
• 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
• Performs internal audits as assigned per the internal audit schedule;
• Conceptualize and Perform data analysis;
• Compiles and presents quality data in management review;
• Generates, maintains, and updates risk management documentation throughout the life cycle of a product by assuming ownership of risk assessment and management processes
• Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert;
• Performs other duties as may be required by management.

Skills and Experience:

• A minimum of a BS in Engineering is required
• Additional qualifications and certifications in areas of quality management, regulatory affairs especially in medical devices as necessary
• Develop and maintain strong, positive business relationships with key internal customers such as R&D, Project Management Office (PMO), Clinical, Regulatory Affairs, Sales and Marketing, and Finance (as appropriate) to fulfill design development activities, support audits/inspections, and develop and implement quality plans that will ensure company compliance with regulatory requirements.
• Gain a full understanding and knowledge of how LivaNova devices are designed and manufactured, how they function, and how they deliver clinical benefit.
• Maintain and improve technical knowledge in area of expertise to provide value added feedback for new product development, investigations, and product/process changes to ensure the safety and effectiveness of LivaNova devices.
• Collaborate with other areas within Quality to achieve quality objectives.
• Appropriate written and verbal communication skills in English and in any other relevant language(s).
• Experience working in a regulated environment industry such as a FDA medical device manufacturer.
• Technical education and experience in an area relevant to LivaNova devices.
• 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 of prioritizing and planning activities with specific attention to understanding expectations of internal personnel and external stakeholders.
• Good team player: open and honest when communicating with peers and management. Resolves most issues with peers, but understands what issues are important to escalate to management.
• Strong interpersonal skills
• Sustained record of performance during tenure in previous position as shown through consistency with which metrics in their areas of responsibility meet performance objectives as established in Management Review and a track record of implementing improvements.
• Occasional travel may be required.

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 d…

  Stellenlokationen:

80331 München, BAYERN, DEUTSCHLAND