stillingsbetegnelse: Quality Engineer

jobbeskrivelse:
Job Description CeQur ApS is located in Nordborg, Denmark and Marlborough, US. The company is focused on development and commercialization of simple insulin delivery devices. We are a team of entrepreneurially minded engineers, and scientists, working in close collaboration to bring our insulin device from a prototype phase into a full scale consumer product that will improve everyday lives of diabetes patients. CeQur ApS is now looking for an engineer to be part of the quality team in Denmark with an opportunity to participate in the development of highly specialized medical equipment in a close team-work environment. The candidate will be an engineer with experience in completing verification and validation of manufacturing processes as well as overall quality engineering knowledge. Quality Engineering Support As our new Quality Engineer, you will be responsible for supporting the qualification of production and testing systems as well as supporting ongoing production. You will also assist in the development and implementation of the Quality Management System for CeQur in Nordborg. More specifically, your areas of responsibility include: - Supporting the development of process parameters through design of experiments and other techniques in order to define a robust process window with a low degree of variation. - Developing and executing protocols for process validation and for verification or validation of Software. - Supporting/leading the development and continuous improvement of production including the development of process risk plans. - Supporting incoming inspection, in-process and final inspection, when required performed quality control activities. - Conducting failure analysis on devices to determine root cause(s) and identify and suggest corrective actions. - Participating and supporting the Manufacturing Review Board’s activities, manufacturing process audits, working with key suppliers to establish qualified measurements, process quality planning and process controls. Quality Systems Support Another part of your job revolves around quality systems support where you may support the Document Control process for our Nordborg site and act as backup for Document Control for our US site. Moreover, you provide training and awareness on quality systems and compliance requirements and support the quality team with improvement initiatives of the quality management system. You also perform process audits as well as internal and supplier quality system audits. Skills/Experience/Education Requirements: Analytical Skills o Ability to apply technical knowledge to a specific scenario within CeQur, creating value by recommending and implementing solutions to complex problems. o Ability to understand and break down complex situations and problems. o Understanding of specifications in drawings and blueprints allowing you to translate product and product specifications into test and inspection methods. o Understands and applies statistics in the manufacturing environment including hypothesis testing, design of experiments, process capability and control charting. Communication and Leadership Skills o Solid communication and team-work skills. o Self-driven individual with leadership skills, able to resolve quality-related issues in a timely and effective manner. o Ability to write routine reports and correspondence. o Speak and write English fluently. Danish language skill is preferred. Experience o Engineer with experience from a regulated industry. o Practical experience conducting tests and writing technical reports. o Worked with quality tools/methodologies and preferably, knowledge of FDA, GMP, ISO 13485, and ISO 14971 (including FMEA method). o Worked with product and/or process development with improvement methodologies (e.g., Six Sigma and Lean Manufacturing). Education o BSc or MSc in Engineering or related technical degree combined with 3+ years’ experience in a regulated industry, prior medical device experience is p

Arbejdsgiver Navn: CEQUR ApS

Arbejdsgiver telefonnummer: 7488 1631

Sådan ansøger: careers (at) cequr.net

Job kort beskrivelse: Ingeniørarbejde i industri og produktion

land: Danmark

region: Syddanmark

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark