Quality Assurance Manager Combination Products and Medical Device (temp, 100%)

Congenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step. **Your Responsibilities** - Act as the quality single point of contact for assigned device development or industrialization projects for combination products and medical device - Ensure adherence to applicable design control and risk management requirements - Collaborate across functions to ensure robust quality at the interface between the drug product and device component within the combination product - Develop and deploy risk management plans and reports; actively participate in and facilitate FMEAs - Define specifications, including the drug product–component interface - Drive investigations and change control assessments - Represent the department at quality and change review boards - Advise and consult customers and suppliers (take indirect leadership as appropriate) **Your Skills and Experience** - Bachelor of Science (BSc) in life sciences discipline or chemical/mechanical engineering - Professional background: 5+ years of experience in device quality or device development within the pharma or medical device industry - Experience in project management in the pharma industry with tools Six Sigma / DMAIC is preferred - Hands on expertise in applying risk management concepts and tools, and deploying design control for combination products - Sound knowledge of cGMPs and relevant international regulatory requirements (QSR; MDR; ISO13485, etc.) - Confident in presenting, networking, and building relationships - Team player who works efficiently and flexibly within interdisciplinary teams in global environments - Decision maker, taking the lead where appropriate and necessary - Fluent in English - written and spoken, German is a nice to have - This contract is limited to one year with an option for extension **Your Benefits** - You will work in the Basel area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere - You benefit from flexible working hours and an exciting and versatile field of activity - You work in a company with a flat hierarchy, short decision-making processes - You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation - You benefit from modern and attractive working conditions and development opportunities - An attractive salary and very good social benefits round off the offer Quelle: https://ch.linkedin.com/jobs/view/quality-assurance-manager-combination-products-and-medical-device-temp-100%25-at-congenius-ag-4328024871

Level: senior