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Gilbert, Arizona Cyber Sphere LLC
Job title Quality engineer with strong medical devices experience (MNF) location Gilbert,AZ Fulltime 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 Senior Quality Engineer (perm position) middot Medical device mnf exp (MANDATORY) middot Experience with reviewing and revising quality documents middot Expert at reviewing validations documents middot Keen understanding of details that need to be confirmedchecks for movement of people and equipment middot Go thru documents for accuracy (ensure there is objective evidence for quality reviewsauditing) middot Work cross functionally with other departments ndash Mnf., RD, RAQA etc. and explain positioning of quality o Excellent interpersonal and written communication skills to communicate effectively at all levels middot 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 middot Able to hold healthy debates middot Experience guiding teams on quality matters teacheducate middot There is a QMS in place middot MUST have experience working on a manufacturing floor middot MUST have medical device experience middot Travel between 2 sites frequently (located a couple miles apart) ndash MesaGilbert Mesa site will be moving to the Gilbert location in 2021. middot Experience working with FDA middot May be open to relocation for the right person middot Minimum 10 years related experience in the medical device field andor training or equivalent combination of education and experience, including experience at management level. middot BS degree MANDATORY middot 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. middot GCP or GMP experience is a plus. middot Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma GB or CQE preferred. middot Position may move to a supervisory role soon ndash experience leading or supervising others a PLUS Regards Vinay Ram CYBER SPHERE LLC httpr20.rs6.nettn.jsp?f001M435Yc8c5f3abLLN6LrigN465HN1We7LM3rYfJKrcxLHpsQZUq8q0tL760ACfByjTKbrJby92men5leRTKreAGOZP3vB7OuqEwYw45yATcVxxNKwzhtTq5PR3TODK9dYYMF1lCklNpDmDe1VDTwampcK6m1cLKlopnwVVMNnAxhkSn2bbszRCc5jHYZ5Kmnf2GNIaGeml9Digampch4-7Z5KodH0UcRztBVBMT0hdbhDB4Edy8DoFUgKmgwMEFJCk4ZSpT7g