Quality Engineer

Akkodis is seeking a Quality Engineer for a 12 Months Contract position with a client located in Horseheads, NY.Pay Range: $35/hr - $40/hr (The rate may vary based on experience, education, geographic location, and other factors.)Overall responsibilitiesPosition duties and responsibilitiesConduct 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.Experience:Bachelor's degree required, bachelor’s degree in engineering preferred, or equivalent combination of education and experience.Experience working in both an FDA and European regulatory environment is preferred.This position will require relevant experience working in manufacturing/operations..If you are interested in this Quality Engineer job, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com. If you have questions about the position, please contact Ajay Kumar at .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-policy.The 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