Quality Engineer

Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.Job DescriptionDescription:The Quality Engineer is responsible for maintaining a good vendor/customers relationship by consistently exceeding customer specifications, throughout proper product development and supply in a world-class condition. All systems/criteria shall be developed, documented, and maintained to ensure consistent quality assurance.Essential Duties and Responsibilities:Maintains adherence to product quality standard in department for incoming materials and finished goodsIdentifies and records any problems relating to product, process, and quality systemCoordinates Customer Approved 3rd Party Quality System RequirementsInitiates, recommends, or provides solutions through designated channelsManages reduction of further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been correctedRepresents the Company to our Customer and vendors, including quality-related supplier visits and contacts as approved by the Quality ManagerMakes independent decisions/referrals to resolve potential quality problems when appropriateAssists in development/adherence of Quality Manual and Quality Lab set-upThinks, resolves, and documents all quality issues in a disciplined, 5-phase processAnalyzes data and performance, and evaluates quality of incoming and outgoing productControls product quality through development and use of FMEA's, Control Plans, Flow Charts, and SPCCreates computerized graphs/reports that clearly demonstrate quality characteristicsCompiles and submits sample submissions to Customer; receives and reviews sample submission from vendorsUnderstands, operates, and performs minor repairs on various types of laboratory test equipment and checking fixturesEvaluates supplier PPAP packageMaintains "operator documents” and QC recordsMaintains flexibility in ability to adjust to changes in job requirements and hours while completing other functions on a daily basis without failReports to Quality Manager as well as Department Managers to keep all informed of issuesReads blueprintsAssists in problem solvingPerforms functional quality tests as requiredEducation Required and Preferred:BS degree in a technical discipline or equivalent experience requiredASQC/CQM/CQE certification preferredExperience Required and Preferred:3-5 years of quality engineering experience preferredLanguage Skills:Ability to read and interpret documents such as safety rules, blueprints and procedure manuals. Candidate has the ability to write routine reports and correspondence.Mathematical Skills:Ability to add, subtracts, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Candidate has the ability to compute rate, ratio, and percent and to draw and interpret bar graphs.Reasoning Ability:Candidate has the ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.Other Skills and Abilities:Must be computer literate and familiar with appropriate software programs. Candidate has the ability to create visual aids for communication purposes.Additional InformationAll your information will be kept confidential according to EEO guidelines.