Supplier Quality Engineer

Akkodis is seeking a Supplier Quality Engineer for a client located at Horsehead NY. This is a 12-month contract Position.Pay Range: $40 - $50/hour; The rate may be negotiable based on experience, education, geographic location, and other factorsYour Responsibilities will Include:To be a technical focal point for the work cell to work on supplier quality issues directly with the Supplier Quality Engineering group and communicate status on non-conforming parts/suppliers across the work cell product at the site level.Responsibilities:-Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.Lead and maintain Material Review Board. Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.Support Base Business and Production Improvement Initiatives.Conduct audits to good manufacturing practice and applicable standardsReport on supplier performance metrics and management reviews.Oversee audits of all quality system categories to assess compliance to process excellence standards.Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management.Handle complex technical issues for manufacturing processes that are to be transferred to other facilities. Provide quality engineering support to suppliers including audits, assessments, inspection technique support,verification/validation activities, CAPA and change management. FDA CFR Part 820 and ISO 13485 regulations and standards.Develop standard operating procedures, specifications, and provides technical transfer and validation support.Audit and approve manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures.Provide data and documentation in support of the development of validation strategies.Provide sampling plans and approve inspection methods for evaluation and testing of components and products; support and expertise in reliability planning and reliability growth demonstration during new product development.Provide support and oversee Purchasing Controls, Approved Supplier List, supplier selection processes and supplier quality agreements.Supports and leads projects related to quality and performance improvements.Supports and oversees additional supplier quality, purchasing controls and quality assurance activities. Other responsibilities may be assigned & not all responsibilities listed may be assignedEnsure effective quality strategies for validationCarry out OQ and PQ validationEnsure that all non-conforming materials held in Receiving Inspection are released to stock or production floor in a timely manner. Provide feedback of issues encountered to SQE II.Provide guidance to Receiving Inspectors.To provide documentation to perform Inspection of components per Inspection Plans in SAP.To be the focal person for work cell related quality and functional product issues that stem from components being purchased for manufacturing.Evaluate component failure rates from production line, collect samples and initiate Failure analysis to drive continuous improvement activity to component manufacturer.Assure that non-conforming materials to be returned to vendor due to poor quality have the appropriate documentation that describes the reasons for return (5W, 2H).Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.Comply and follow all procedures within the company security policy.Education Requirements:Bachelor's degree required, bachelor’s degree in engineering preferred, or equivalent combination of education and experience. Experience:Experience working in both an FDA and European regulatory environment is preferred. This position will require relevant experience working in manufacturing/operations.Interpersonal skills / characteristics (if applicable):Advanced PC skills, including training and knowledge of software packages. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Ability to define problems, collect data, establish facts, and draw valid conclusions.Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.Strong verbal and written communication skillsOther requirements (if applicable):Knowledge of product/process Risk Management (FDA and ISO standards) is required.Experience with a proven track record of implementing appropriate risk mitigation. Technical training and experience using Risk analysis (DFMEA, PFMEA), Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Gage R&R, etc. Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making. The ability to perform \"hands on\" troubleshooting and problem solving is required. The ability to think on the feet and providing sound judgment is highly desired. Good technical understanding of manufacturing equipment and processes is required. Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred. A thorough understanding of GMP/ISO regulations and validation regulations is preferred.If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Punit Pathak at 610 445 8219 or .Equal Opportunity Employer/Veterans/DisabledBenefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policyThe Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:· The California Fair Chance Act· Los Angeles City Fair Chance Ordinance· Los Angeles County Fair Chance Ordinance for Employers· San Francisco Fair Chance Ordinance