QA/RA Officer
Envista
Job Description:The global center of Software Development for Envista, Medicim, located in Mechelen, is world leader in innovative software solutions for the dental profession. We investigate, develop, maintain, and support innovative software solutions for clinicians and dental technicians. Our software solutions create intuitive workflows for image acquisition, diagnostics, treatment planning, prosthetic CAD/CAM, and dental team collaboration to treat patients better. DTX Studio is our flagship software suite. We want to shape the innovation and the industry.We are looking for QA/RA Officer to join the Quality Assurance and Regulatory Affairs team.The QA/RA Officer will:Support QA/RA with the maintenance of the Quality Management System documentation to ensure compliance applicable medical device regulations.Provide administrative support for notifications and submissions.Review of records as document controller.Maintain training documentation and ensure timeliness of training.CAPA management, support with root cause investigation and administrative support in CAPA’s.Assist with internal and external audits.#LI-EU1Job Requirements:Bachelor’s degree or higherExperience in Medical Device or other regulated industryExperience in Quality Assurance or Regulatory AffairsFluent in English, good oral and written communication skillsPragmatic problem solver with attention to detail and completeness.Proactive work ethic.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.
Brabant Flamand – Malines, Anvers
Fri, 09 Aug 2024 22:42:32 GMT
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