Support the quality team with the implementation of the Quality Management System and work closely with another team to ensure quality is understood and implemented throughout the entire company.
Main Responsibilities: Provide support to the organization including the Quality department to maintain the overall quality system; Execute and maintain several QMS processes and support the process owners; Create and maintain QMS documentation, such as standard operating procedures; Work with relevant departments and stakeholders to investigate non-conformances, defects and process failures in general; Support analysis and improvement process and implement corrective actions to prevent re-occurrence of compliance issues; Ensure that QMS procedures are followed and provide advice and guidance on quality-related aspects. Ensure appropriate equipment controls are being implemented at the company lab and other premises by supporting the maintenance and calibration activities together with the different equipment and lab ow ners Ensure acceptance and Inspection activities for each product are established, appropriate, and carried out in accordance with procedures and Control Plans; Establish inspection standards, plans, frequencies, and test methods for the product realization process Support risk management activities Lead and coordinate the creation and maintenance of FMEAs Support Internal Audit process and Supplier Audit process as per ISO 13485 requirements Coordinate administrative activities related to eQMS system, including supplier monitoring and incoming inspection coordination. Ensure fulfillment of lab policies by monitoring activity following Control Plans. Your profile Master's degree or equivalent in Engineering, Life Sciences or another relevant discipline (preferred); 2-3 years of experience in quality in the medical device industry Good knowledge of ISO 13485, ISO 14971, MDR 2017/745, FDA 21 CFR 820; Team player and positive individual Attention to detail and accurate Hands-on and creative Spanish is a plus Why us? We are looking for someone who Is ready to proactively bring new ideas to the team, push boundaries and constantly look for innovation. At INBRAIN we believe on shared success and diverse ways of thinking, here you'll learn, grow and advance in an innovative culture
WHAT CAN WE OFFER TO YOU? Acollaborative environment where innovative ideas flourish and teamwork drives us forward. At INBRAIN, we believe the power of collective intelligence is unique. You will be part of a team that thrives on open communication, knowledge sharing and mutual respect. Meaningful Work Impact:Our projects are not only exciting and challenging but also have a positive impact on the industry and society as a whole. You'll be part of a team that strives to create meaningful change. Cutting-Edge Technology Exposure:Joining us means immersing yourself in the latest technologies and innovative solutions. You'll have access to state-of-the-art tools and resources, fostering continuous learning and keeping your skills relevant in a rapidly evolving industry. Competitive salary (according to your experience/skills) Payflow & Flexflow Private Health Insurance (optional) Training bonus for professional development. 23 vacation days per year + 24th and 31st of December. Hybrid working modality Applications must be submitted in English
At INBRAIN, we're not just offering a job – we're inviting you to be part of a transformative journey, Are you ready to transform lives? Join us!
#diverseandinclusive
We believe that a diverse and well-balanced workforce drives innovation. At INBRAIN, we foster the inclusion of all people regardless of culture, age, gender, sexual orientation identity or any other status
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