Arbejde Quality Engineer Syddanmark CEQUR ApS - jobtilbud
jobbeskrivelse:
CeQur Company CeQur, a company focused on the development and commercialization of simple insulin delivery devices is located in Nordborg, Denmark and Marlborough, US. We are a team of entrepreneurially minded engineers, and scientists, working in close collaboration to understand the disease of diabetes and are committed to create patient-focused managed care solutions to improve everyday lives of diabetes patients. CeQur ApS is now looking for a Quality Engineer to be a part of the Quality team in Denmark with focus on the manufacture of one key product component, a micro capillary with high precision flow resistance. Capillary manufacturing is currently based on our pilot manufacturing plant and in parallel with this new automatic equipment will be developed and take manufacturing capability to a new level for full scale-up. This position will be based in Nordborg requiring minor travel to Marlborough, USA. Job Description We are looking for a Quality Engineer with experience in completing verification and validation for in-line manufacturing processes as well as product qualification tests. This position will offer the opportunity to participate in the development of highly specialized equipment in a close team-work environment with engineers, physicist and technicians. Responsibilities The Quality Engineer will be responsible for the qualification of production systems and to support ongoing production and will assist in the development and implementation of the Quality Management System for CeQur Production in Nordborg. Areas of specific responsibility include: Production Quality ? Participate / lead validation and qualification of Capillary production and testing processes. ? Support the development and continuous improvement of Capillary Production including developing process risk plans (pFMEA). ? Support and performed Quality Control activities; incoming inspection, in-process and final inspection. ? Participate in the Manufacturing Review Boards (MRB) activities. ? Working with key suppliers to establish qualified measurements, process quality planning and process controls. ? Perform manufacturing process audits. Quality Systems Support ? Lead Document Control process for DK site and backup for Document Control for site in US. ? Provide training and awareness on Quality Systems and compliance requirements. ? Perform internal and supplier audits. ? Support the Quality team with improvement initiatives of the Quality Management System. Background and qualifications ? 3+ years experience, in a regulated industry, prior medical device experience is preferred. ? Engineering experience and demonstrated use of Quality tools/methodologies. ? Knowledge of FDA, GMP, ISO 13485, and ISO 14971 (including FMEA method) are preferred. ? Solid communication and team-work skills. ? Self-driven individual with leadership skills, able to resolve quality-related issues in a timely and effective manner. ? Experience with product and process development and improvement methodologies (e.g., Six Sigma and Lean Manufacturing). ? Understands specifications in drawings and blueprints. Translates product specifications into test and inspection methods. ? Understands and applies basic uses of statistics in the manufacturing environment including gage R&R, sampling plans, design of experiments, process capability and SPC and used in technical report writing. ? Able to read and write fluently in English. Danish language skills are preferred. Education A BS or MS in Engineering or related technical degree is required. Reports to: Quality Systems and DK Leader Contact Bettina Collin BKC (at) cequr.com or Juan Carlos Ospina (+45 2048 6678) juan.ospina (at) cequr.com
Arbejdsgiver Navn: CEQUR ApS
Arbejdsgiver telefonnummer: 7488 1631
Sådan ansøger: careers (at) cequr.com
Job kort beskrivelse:
Andet ingeniørarbejde (undtagen elektroteknologi)
land: Danmark
region: Syddanmark
Kontrakt varighed: Fast
Kontrakttype: Fuldtid
krævede uddannelse: Ikke angivet
Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark
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