- 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
- 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 Medical devices -- Quality management systemsISO Medical devices -- Application of risk management to medical devices21 CFR 820 - US FDA Quality System RegulationMDR - Medical Device Regulation 2017/745.
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Beschreibung
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:
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Job Requirements:
Operating Company:
Nobel BiocareEnvista 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.
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