Quality Engineer Products and Systems

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.

The Company

A leading health technology company focused on improving people's lives through education, engagement, and empowerment they make it possible to help those affected by the disease live a fulfilling life. Innovation, a systematic approach and a path to value is how they distinguish themselves. An organisation with an international character and a lot of opportunities to develop yourself and grow.

Role Description

You will hold the Quality Engineering role in a New Business Development venture in the cardio-vascular field. The company has a strong and unique position in this field through its interventional X-ray, cardiovascular devices and ultrasound portfolio. We are developing a new image-guidance solution based on a revolutionary navigation technology, encompassing a combination of medical consumable devices and imaging equipment. Your challenge is to ensure that these new solutions and ways of working meet the quality requirements to help to make the product a commercial success.

Responsibilities

• Ensures that appropriate Quality Plans are made that include all stages of the life cycle of the product and supports Quality Plan design
• Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle
• Performs independent technical assessment on product quality performance and post-market product quality analysis
• Can Lead quality related problem solving and root cause analysis during design and manufacturing
• Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
• Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone

Requirements

• Rich experience in the field of design transfer and post-market quality assurance
• Preferable experience on reliability engineering
• Innovative mindset & entrepreneurial spirit, hands-on approach
• Passionate personality with outstanding communication and interpersonal skills
• Academic degree or comparable working experience, excellent analytical and conceptual skills

Other information

must have items
- Experience in Design Transfer & Post Market Quality Assurance; ability / willingness to travel when needed

nice to have items
- Reliability Engineer experience

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ravi Ramnarain Singh.