Job Description:

The Quality Assurance Engineer is part of the quality department and supports different roles and functions within the organization related to New Product Introduction projects, Life Cycle Management activities and the Quality Management System.

The Quality Assurance Engineer Nobel Biocare is responsible to:

• ensure a compliant execution of new Product Introduction projects and Life Cycle Management activities including the review and approval of design control and change control relevant documents, in accordance with internal procedures and applicable regulatory requirements

• act as a consultant for teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities

• participate in change control activities (review and approval of change requests)

• participate in design review meetings and review of respective documentation

• support process owners in the creation and update of procedures

• support audit activities

• support Risk Management activities

• support and participate in Corrective and Preventative Action activities

• develop / update Quality Management System procedures and templates

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Job Requirements:

• Higher education (bachelor or master degree in engineering or science).

• 2 Years of experience in the medical device industry or equivalent regulated industry (preferably in product development, quality management, risk management or manufacturing of medical devices).

• Understanding and knowledge on standards and regulation including but not limited to:

• ISO 13485 - Medical devices -- Quality management systems

• ISO 14971 - Medical devices -- Application of risk management to medical devices

• 21 CFR 820 - US FDA Quality System Regulation

• MDR - Medical Device Regulation 2017/745.

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 .