QA/RA Officer in Flemish Brabant, Belgium

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.

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Job Requirements:

• Bachelor’s degree or higher

• Experience in Medical Device or other regulated industry

• Experience in Quality Assurance or Regulatory Affairs

• Fluent in English, good oral and written communication skills

• Pragmatic problem solver with attention to detail and completeness.

• Proactive work ethic.

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 .