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Quality Engineer (m/f/d)

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LivaNova

1mo ago

  • Job
    Full-time
    Entry, Junior, Mid & Senior Level
  • Engineering
  • Munich

AI generated summary

  • You need a Bachelor's in Electrical Engineering or similar, quality engineering experience in MedTech, strong English/German skills, problem-solving ability, and knowledge of statistical tools.
  • You will lead quality improvement initiatives, manage non-conformities, define design requirements, analyze data, drive tests, support audits, and enhance processes to ensure compliance.

Requirements

  • 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

Responsibilities

  • 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

FAQs

What is the primary location for this Quality Engineer position?

The primary location for this Quality Engineer position is Munich, Germany.

What is the main focus of the Quality Engineer role?

The main focus of the Quality Engineer role is to contribute to the quality strategy for Cardiopulmonary equipment development and manufacturing processes, ensuring quality and effectiveness of the devices used to treat patients.

What educational background is required for this position?

A minimum of a bachelor’s degree in electrical/electronic engineering or a similar qualification is required, along with relevant experience in electronic or electro-mechanical products in highly regulated industries.

Is experience in the MEDTECH industry required?

While experience in the MEDTECH industry under a quality function is advantageous, it is not strictly required.

What language skills are necessary for this role?

Good verbal and written communication skills in both English and German are necessary for this role.

What kind of travel is expected for this position?

The role requires 5% - 25% travel.

Are there any specific skills that would be advantageous for this role?

Yes, skills in Lean & Six-Sigma, regulatory affairs knowledge, and a good understanding of statistical tools such as Minitab would be advantageous.

What personal qualities are important for a candidate applying for this position?

Important personal qualities include being a problem solver, pragmatic and result-oriented, a good team player, having an innovative mindset, and being adaptable to changing priorities.

What benefits are offered with this position?

The position offers a competitive base salary, variable short-term and long-term incentives, a supportive and collaborative work environment, and recognition through the STARS Program for contributions and achievements.

How does LivaNova approach diversity and inclusion in its hiring process?

LivaNova values equality and celebrates diversity, ensuring that the recruitment process is fair, transparent, and free from unlawful discrimination based on various protected classifications.

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LivaNova

Improving Quality of Life Through Innovation. Every Patient, Every Day

Manufacturing & Electronics
Industry
1001-5000
Employees

Mission & Purpose

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. At LivaNova, we understand the importance of bringing both clinical and economic value to our customers. We are a strong, market-leading medical technology and services company, offering a diverse product portfolio and global reach. LivaNova is listed on the NASDAQ stock exchange under the ticker symbol “LIVN.” LivaNova has approximately 2,900 employees worldwide. We are headquartered in London (UK) and maintain a presence in more than 100 countries. LivaNova is a worldwide leader in cardiopulmonary and neuromodulation, dedicated to creating meaningful products and therapies that transform lives each and every day.