Job Description:
Responsible for maintaining the company's quality management system.
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Coordinates the updating and maintenance of procedures and other quality system documents.
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Performs the issuance and distribution of procedures, work instructions, forms, visual aids and other quality system documents.
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Manages the quality system training system.
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Maintains quality system records; such as: TR's, MRDR's, complaints, CAPA's, GMP's, variances, audit reports and certificates from BSI, FDA, COFEPRIS, etc.
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Collaborates in the preparation and coordination of the internal audit program of the quality system.
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Participates in external audits of the quality management system: ISO 13485, GMP, COFEPRIS, FDA and other regulations.
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Performs internal quality system audits and patrols on good manufacturing practices for medical devices.
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Prepare the monthly report of QA KPIs, GMPs and MRDRs.
Job Requirements:
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Industrial Engineer, LAE or similar.
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Basic knowledge of reading plans and measuring instruments.
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Knowledge of the ISO 13485 standard is desirable.
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Preferably have had experience in a similar position.
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Desirable English language and good writing.
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Knowledge of using Microsoft Office.
Operating Company:
Ormco
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.
What We Do
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 partners deliver the best possible patient care through industry-leading products, solutions, and technology. Our comprehensive portfolio covers a wide range of dentists' clinical needs for diagnosing, treating, and preventing dental conditions, as well as improving the aesthetics of the human smile.
Our differentiated combination of continuous improvement, a bias toward action and innovation, and a deep respect for the more than one million professionals we serve embolden us to champion dental professionals like no one else can.
The operating companies that form Envista, including Nobel Biocare, Implant Direct, Ormco, DEXIS, Kerr, Metrex, and more represent more than 125 years of dental industry excellence. These brands meet the end-to-end needs of dental professionals worldwide.
We are committed to helping dental professionals improve their patients’ lives by digitizing, personalizing, and democratizing oral care. Every day, our products and solutions are accelerating the future of dentistry. Operating with high sustainability standards guides our decision-making so that we can deliver enhanced outcomes for our people, the environment, and communities.
View our Environmental, Social, and Governance report at https://bit.ly/Envista2022ESG to learn more about our commitment to sustainability.
Learn more at www.envistaco.com
