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Senior Quality Engineer

Job Summary TheQuality Assurance Engineer isresponsible for quality assurance activities with oversight ofinvestigations, the Quality Management System SOP's, validations and quality continuous improvements. This positionreports into the QA Manager. MAJOR JOB DUTIES AND RESPONSIBILITIES  (List in order of importance) Use Quality Engineering principles, tools and techniques to develop and optimize systems and processes so that they are aligned with company strategy and regulatory requirements. Provide support for customer, regulatory and internal audits. Use root cause analysis and risk assessment tools and techniques to perform investigations and determine appropriate corrective action. Lead, coordinate and maintain validations for all departments. Lead, coordinate and maintain Calibration Program. Lead, coordinate and maintain Environmental Monitoring Program. Conduct audits (both internal and supplier) and monitor compliance with ISO and FDA Quality System Regulation standards. Collect, review, and interpret data for trend report, metrics, quality system review and complaints. Update approved supplier index as required. Review and approve quality assurance procedures and reports. Maintain SOP's and Quality Management System as directed by QA Manager. Performs other duties as assigned. QUALIFICATIONS (Education/Training, Experience and Certifications) Bachelor's degree in a natural/life science discipline with knowledge and experience in one of the following areas; Chemistry, Biology, Microbiology or cell culture; or an equivalent combination of education, certification and experience CQE/CQA certification preferred KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently) Minimum 3-5 years relevant experience Excellent written and oral communication skills are required Able to interface effectively with all levels of employees Must be proficient in MS Office (Word, Excel, Access) Experience in deviation and complaint investigations, including root cause analysis tools and technical writing required Must be detailed oriented, with strong organizational skills, ability to multi-task, prioritize work load and work independently to meet commitments with minimal supervision Experience conducting and supporting audits is required. 105895
Salary Range: NA
Minimum Qualification
Less than 5 years

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