Leica Microsystems (Schweiz) AG is part of the international Leica Microsystems group, a world leading company for microscopy and laboratory technology. Since 2005, we are part of the successful American Danaher Group. At our Swiss location in Heerbrugg, we are developing and marketing surgical microscopes for medical applications, as well as, stereo and digital microscopes. The consistent development of innovative products makes Leica Microsystems a successful, globally active company in a leading market position.
Quality assurance during design, development, verification, and validation, as well as, design changes of Leica Microsystems Surgical Operating Microscopes and Accessories;
Verifying new product development and design changes to ensure compliance to
ISO 13485, FDA 21 CFR Part 820 and other international regulatory requirements. You will actively participate in such projects representing both quality assurance and the customer;
Supporting the RA/QA Manager and Project Leaders during internal and external audits;
Performing design transfer reviews at our contract manufacturer in Singapore;
Organizing training sessions on Quality System Regulations related to Design Control;
Supporting, or where appropriate, taking leadership on CAPA for product quality issues.
Bachelor's degree (BA/BS) from four-year college or university in science, engineering or equivalent;
Minimum 2-3 years proven QMS, QA and/or RA and/or R&D experience with medical electrical devices in an FDA-regulated industry, or equivalent combination of education and experience;
International experience in problem solving, complaint handling or equivalent, ideally from a R&D or RA/QA environment;
Knowledge of US and EU medical device regulatory requirements;
Fluent in English (mandatory) and preferably German also.
Danaher Corporation designs, manufactures, and markets professional, medical, industrial, and consumer products, which all generate approximately $13 Billon in revenue. Danaher’s business activities encompass four reporting segments and are comprised of six strategic platforms: Medical Technologies, Professional Instrumentation (Environmental, Electronic Test), Industrial Technologies (Motion, Product ID, and Focused Niche Businesses) and Tools & Components (Mechanic’s Hand Tools).
Danaher operates globally with about 50% of its revenues derived from outside the United States. The Company has significant operating businesses headquartered in Europe and has greatly expanded its operating presence in Asia over the past several years. Danaher is a well-capitalized business, which has historically used available cash flow to fund acquisition activity. Culturally, the company operates in a highly de-centralized model with an extremely lean corporate structure. Danaher has a proven system for achieving performance: the Danaher Business System (DBS). It drives every aspect of the group’s culture and performance. DBS is a system of continuous improvement and is used to guide and measure everyday activities, which has enabled it to double in size about every 5-years with impressive financial performance.
Quality and Regulatory Affairs