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Gilbert, Arizona Reddaiah, Inc
Senior Medical QA Engineer - Gilbert, AZ onsite FT perm. 90-95kyear plus benefits. FT Perm role in Gilbert, AZ ONSITE 100 Candidate will mainly partake in validation activities, provide feedback, review, documentation, activities, guidance, give feedback, review and write validation. High focus on validation and supporting of audits. Pharma background would not be considered for the role. It is different. Must be medical device background and document validation activities. Should have good background in FDA audits. Software validation beneficial but not required. Heavy on validation. Eventually they will have direct reports, not now. Understands regulations for FDA (EuropeChina). Emphasis on validation and regulation design control. When designing a new product, there is a regulation requirement. Design Control and release management. Compliant with regulation with new product requirement. Regulatory audits, inspections. Experience with the below mandatory, must be on resume Validation Master Plans, creating and reviewing. ISO 14971- Risk Management ISO 14969 - Quality System for Medical devices ISO 13485 and FDA Quality System Regulation 21 CFR part 820. 10+ yearsrsquo experience in a Senior Device Quality Engineer role. Must have at least 4+ years recent MEDICAL DEVICE experience. Official JD Senior Medical Device Quality Engineer (perm position) ndash 90-95kyear + benefits ndash Gilbert, AZ MUST have Medical device manufacture experience ndash Does candidate have this? If so, is it on the resume and how many years? MUST have experience working on a manufacturing floor Experience working with the FDA Minimum 10 years related experience in the medical device field andor training or equivalent combination of education and experience, including experience at management level. BS degree MANDATORY Technically sound in quality systems and be abreast of developments in the Quality Assurance field. Including practical application of ISO 13485 and FDA Quality System Regulation 21 CFR part 820. Experience with reviewing and revising quality documents Expert at reviewing validations documents Keen understanding of details that need to be confirmedchecks for movement of people and equipment Go thru documents for accuracy (ensure there is objective evidence for quality reviewsauditing) Work cross functionally with other departments ndash Mnf., RD, RAQA etc. and explain positioning of quality Ability to push back in a professional but stern manner ndash ask questions and convey in a collaborative tone the positioning of reasons able to push back professionally based on factsprotocols in place for compliance Able to hold healthy debates Experience guiding teams on quality matters teacheducate There is a QMS in place GCP or GMP experience is a plus. Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma GB or CQE preferred. Position may move to a supervisory role soon ndash experience leading or supervising others a PLUS