Quality Engineer

Quality Engineer Medica USA is looking for a motivated Quality Engineer. The candidate will understand how to identify nonconforming products and investigate to identify the root cause of issues. Specifically, this position will investigate nonconforming devices to identify failure modes, collaborate to write and implement process improvements based upon the failure analysis results, and report on failure trends. In addition, this role manages suppliers to ensure they are qualified as per quality system requirements, provide materials of high quality that meet specifications and implement proactive preventive measures when needed. The candidate will also support and help develop pfMEA; conducts risk analysis where applicable, maintains risk management files and support and works cross functionally, specifically, supports engineering and guides engineering as well as operations in accordance with 21 CFR regulations / ISO 13485. Responsibilities Develop SOPs and maintain processes for documenting product requirements, specifications, verifications, and validations. Collaborate with internal and external stakeholders to develop business and customer needs for product development and manufacturing. Resolution of supplier quality issues and management of supplier quality performance -- SQP management, PIQ/PPM metrics, Support for new program launches -- Tech Review, Quality Risk Assessments (QRA). Documentation management and process validation. Quality control (membrane extrusion) + lab testing. Clean room management and monitoring. Work in conjunction with engineering regarding instruments calibration. Training of the personnel while working in conjunction with Medica S.p.A. Work cross functionally to maintain equipment and machines. Facilitate incoming inspections of final products. Identification / traceability / preservation of the products (warehouse). Management of nonconformities / CAPA. Management of nonconforming products. Work cross functionally to review local suppliers’ selection and evaluation. Assistance to Medica S.p.A. for product complaints management and regulatory activities. Additional quality activities as needed. Qualifications 2+ years’ experience in process development or manufacturing process engineering Experience developing and validating medical device manufacturing processes and technologies with an emphasis on design for manufacturability preferred. Interpret and implement specifications Strong mechanical system troubleshooting and general aptitude Micro controls/analysis experience preferred but not required Quality mindset, and ability to identify quality-focused continuous improvement opportunities. Passionate about improving product quality Compensation: $70,000.00 - $90,000.00 per year Medica USA Inc. was recently founded in Delaware, USA, and is fully controlled by Medica Spa. Medica group designs and produces a wide range of disposable medical devices , electromedical equipment and develops fully automatic high productivity machinery . The technological edge of the company is based on the extrusion of hollow fiber membranes for hemofiltration, plasmapheresis and water ultrafiltration. Over the years, R&D activities have been integrated with a highly automated production systems in five different facilities, four in Italy and one in Tunisia , and two commercial entities in US and in China . Thanks to the Group, Medica is able to customize products and offer disposable specifically designed by the customers’ demand. Medica Usa Inc. is focused on the development of the medical business and will deal with the distribution of medical devices produced by Medica Spa in the United States and North America . The company will also identify new business opportunities for the Medica group in the American continent. Medica USA Inc. will deal with the aspects of regulatory with the relevant health authorities. #J-18808-Ljbffr