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Process Validation Engineer

Company: Indotronix International Corporation
Location: Tempe
Posted on: June 25, 2022

Job Description:

Primary focus of this position is to lead EU-MDR submission of products, including product gap assessments, planning and remediation of gaps within project timelines. Successful candidates will assist in developing, optimizing, and validating components/elements of a medical device, write technical documents, validation protocols and reports Required Qualifications: B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering Bachelor's Degree preferred. Experience: 4-7 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 1-3 years medical device or equivalent industry experience). Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization Job Requirements:Support of EU-MDR submissions: leads all R&D activities surrounding EU-MDR submission of Oncology products, including kits and kit components.Product Remediation: coordinates and/or leads all aspects of product remediation activity related to EU-MDR, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering. Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals.Project Management: creates, tracks and meets project schedules. Creates strategic plans and budgets for EU-MDR projects, assesses and manages priorities and leads task completion to ensure project objectives are met. Coordinates with team members, internal and external suppliers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements.

Keywords: Indotronix International Corporation, Tempe , Process Validation Engineer, Other , Tempe, Arizona

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