Job Description:

Responsible for cleanliness & sterilization compliance of design control and manufacturing processes according to the applicable standards.

• Act as SME for cleanliness, disinfection and sterilization in New Product Introduction and throughout the whole lifecycle of products

• Generate and review technical sterilization and cleanliness specifications as part of Technical Files, ensuring these documents are accurate and comply 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

• Support 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)

• Review and update procedures related to product cleanliness

• Perform sterilization (re)validation

• Perform in process monitoring related to product cleanliness and the sterilization.

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Job Requirements:

• 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)

• ISO 11137-1 and ISO 11137-2

• ISO 10993-1

• AAMI TIR35

• AAMI ST72

• ISO 11737-1, ISO 11737-2 and ISO 11737-3

• ISO 14644 series

• Strong background in Chemistry, Biology, Biomedical or Microbiology.

• 5+ years of experience in the field of cleanliness & sterilization in the medical device or pharmaceutical industry

• 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.

• Fluency in English is mandatory, other languages are welcome.

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 .