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Quality Validation Engineer

Company: Experis
Location: Cambridge
Posted on: September 25, 2022

Job Description:

Experis, a ManpowerGroup company, has an exciting contract opportunity with one of our key clients, an American supplier of scientific instrumentation, reagents and consumables, and software services with a mission to enable the customers to make the world healthier, cleaner and safer.Job Description:Quality Validation EngineerLocation: Cambridge, MADuration: 6 MonthsResponsibilities:Supports the manufacturing process owners and other functional area managers as a Quality Management System subject matter expert Leads complex cross-functional quality investigations in a variety of subject matter area to determine root cause and corrective actions. Develops improvements to the Quality Management System to enhance compliance with regulatory requirements. Leads teams to investigate deviations and non-conformances identifying root cause, corrective/preventive actions, and effectiveness of actions taken. Initiates, reviews and approves changes to procedures and processes to ensure compliance with required standards. Contributes expert process knowledge for product and process design and validation teams. Works directly with customers (internal, external, suppliers) on complex critical to quality issues. Leads cross-functional team projects (R&D, Mfg, Vendors, etc). Performs complex statistical analysis to analyze trends, and supports site-level KPI metrics (e.g. yield improvements, CAPA, complaint, and scrap reduction)Minimum Qualifications (must have):Bachelors degree in Engineering or Science Discipline.Minimum 5 years experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Product Advanced knowledge of Quality Engineering principles and practices in a FDA Regulated Environment. Quality standards (e.g., 21 CFR Part 820, ISO 13485)Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis) Computer Systems (e.g. Trackwise, AGILE, SAP)Proficient in team building and leading product quality investigations. Technical report documentation and authoring procedures. Resolution of Customer Complaints and CAPAQuality, Validation, Analytical Instrument, Analytical Method, Process ValidationMore than 7 years overall expPreferred skills: Analytical Instrument experience, Analytical Method, Process ValidationAPPLY TODAY!

Keywords: Experis, Cambridge , Quality Validation Engineer, Engineering , Cambridge, Massachusetts

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