Responsibilities: Role Description: NPI Validation, IQ, OQ, PQ, pFMEA and dFMEA. NPI Validation Engineer 3+ years of medical device experience in NPI, Windchill PLM, under limited supervision, performs and documents moderately comp...
Responsibilities: Ensure that suppliers deliver quality parts, materials, and services. Qualify suppliers according to company standards. Review and approve the documents required to qualify through PPAP process (Control Plan, Flow Char...
Responsibilities: Uses a variety of equipment such as forklifts, conveyers, cranes, handcarts, and power trucks to move materials, parts, assemblies and finished products or goods within a plant, office or warehouse. May maintain records...
Responsibilities : Strong programming skills in SAS / R programming and data analysis. Extensive work experience with large US insurance claims databases, electronic medical records, registry databases for health outcomes research (e.g.,...
Responsibilities: Strong understanding of ISO 13485, MDSAP, EU MDR 2017/745, US FDA 21 CFR Part 820 and applicable regulatory requirements. Excellent level of knowledge and working experience of Quality domain and its related activities....
Responsibilities and Requirements: Automation Inventory Analysis- RPA Project Support CSV In addition to validation and regulation experience, the resource should have the following experience: Be familiar with CSV, especially requiremen...
Responsibilities: Leads all clinical data management activities for assigned clinical studies assuring all timelines are met with best quality. Responsible for overseeing creation and approval of DM study documentation by vendors/CROs (i...
Responsibilities: Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews, and approves engineering changes. Acts as core ...
diagnostic assays. BS in Life Science or equivalent experience is required. Applicants with experience in a GMP/ISO regulated...
Responsibilities: Experience in Test method development & Validation (R&D Verification testing). Good experience in cross functional interactions. Good experience in technical writing skills. Good communication skills. Requirements: ...