**Job Description:** Join our team as a **Microbiological Cleanliness & Sterilization Compliance Specialist** and play a crucial role in maintaining the safety and quality of our products. In this role, you will: + Act as SME for microbiological cleanliness, disinfection and sterilization of both single-use and reusable products during New Product Introduction and throughout the whole lifecycle of products. + Evaluate product and process changes for impact on Sterility Assurance + Generate and review technical sterilization and microbiological cleanliness specifications as part of Technical Files, ensuring these documents are accurate and align with applicable engineering-, medical device- and Nobel Biocare standards + Perform cleaning and sterilization validation and product reusability assessment in order to provide validated instructions for use regarding cleaning, disinfection and sterilization + Ensure company documentation related to sterilization are maintained and updated with most current regulations, standards, and industry practices. + Support and develop a strong interface with cleanliness and sterilization Subject Matter Experts on the manufacturing sites to: + Drive improvements to enhance product cleanliness (cleanroom set-up, product final cleaning, tool cleaning etc) + Ensure that the manufacturing, cleanliness and sterilization process effectiveness monitoring is performed in compliance with regulatory requirements. If you have a keen eye for detail, a strong background in microbiology or biomedical engineering, and a drive to make a difference, we want to hear from you! Be part of a dynamic team dedicated to innovation and quality in the dental implants industry. \#LI-LN1 **Job Requirements:** **Critical Knowledge and Qualifications:** • In-depth knowledge of Quality Management System regulations and the regulations, directives and standards related to microbiology, cleanroom, chemistry and process validation, in particular: + ISO 13485 (Quality Management System for Medical Devices) + Cleaning and sterilization: ISO 11137-1&2&3, ISO 17665-1,2,3, and AAMI ST98. + Contamination control: ISO 14644, ISO 14698, and ISO 8573 series • Strong background in Chemistry, Biology, Biomedical or Microbiology. • Data Analysis: Strong statistical expertise • 5+ years of experience in the field of cleanliness & sterilization in the medical device or pharmaceutical industry **Critical Skills/technical know-how:** • Good interpersonal skills with ability to work effectively with other groups • Excellent verbal & written communication skills. • Strong interpersonal skills with a high level of accurateness, integrity, commitment, ethics and proactivity to cultivate a network of productive relationships in an international matrix environment. • Strong organizational and multitasking skills with the ability to prioritize tasks independently to meet the objectives of multiple projects simultaneously. • Strong analytical skills and result orientation. • Analyzes issues and breaks them down. Makes documented, systematic and rational judgments based on relevant information. • Fluency in English is mandatory, other languages are welcome. • Sound SAP system understanding **Critical Experience:** • Good track record in leading cleanliness & sterilization teams, projects, specifying sterile medical device requirements and conducting cleanliness & sterilization validations leading projects in matrix organizations in the medical device or pharmaceutical industry, preferably in the dental industry. • Comprehensive experience of manufacturing process needs to meet cleanliness requirements. • Experience in working in a highly ambiguous matrix organization. **Operating Company:** Nobel Biocare Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .