Quality Engineer I

The Quality Engineer I will provide Quality Engineering support to all functions for the design, procurement, assembly, test, manufacturing, verification and validation, distribution and post-production activities for medical devices, processes, and quality systems. This is an onsite position in Memphis, TN.Key Duties and Responsibilities: Investigate and resolve process and product issues to eliminate quality problems on products, processes and materials used in manufacturing operations.Assist in the analysis, development and implementation of quality systems.Develop and implement product quality plans, inspections and testing strategies. Provide support for the implementation of process and product qualifications as required.Manage equipment calibration and preventive maintenance schedulesCoordinate and/or implement of Corrective and Preventive Actions. Includes problem identification, investigation, implementation and verification of actions taken to address product, process and/or system issues.Perform supplier capability assessments. Analyze performance data, facilitate problem-solving activities, and develop supplier quality tools and techniques. Coordinate with suppliers to solve process and design problems.Provide direct support for both internal and external regulatory compliance audits.Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. Responsible for maintaining awareness of applicable best practices and regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices such as 21 CFR 820 and ISO 13485.Maintain quality system processes and procedures to ensure compliance with tissue quality management system requirements. Responsible for maintaining awareness of applicable best practices and regulations for compliance with 21 CFR Part 1271.Required Qualifications:Bachelor’s degree0-3 years of experience in medical or mechanical production, test, or inspectionPreferred Qualifications:Basic understanding of problem solving and quality improvement tools and techniquesHigh level of analytical and problem-solving skillsAbility to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.Ability to write reports, business correspondence, and procedure manuals.Ability to effectively present information and respond to questions.Exercise independent judgment in making decisions of a moderate degree of difficulty and complexity regarding product design for quality, reliability, safety, and supplier qualification.Evaluate quality data and determine trends requiring organizational response.Utilize data and information to make decisions and recommendations. Data may include the following: engineering designs and tolerances, test and inspection results, ISO 13485/CMDCAS/MDD and FDA/QSR regulations, Quality Control Procedures, failure data, and life testing information.Apply general problem solving techniques to determine root cause.Employees must be able to relate to other people beyond giving and receiving instructions: (a) can get along with co-workers or peers without exhibiting behavior extremes; (b) perform work activities requiring negotiating, instructing, supervising, persuading or speaking with others; and (c) respond professionally to feedback from a supervisor.Physical requirements:Frequent sitting, walking, and standing.May be required to lift up to 35 lbs. safely.0-20% travelThis position is not eligible for employer based visa sponsorship.Benefits:CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.Competitive compensationExcellent healthcare including medical, dental, vision and prescription coverageShort & long term disability plus life insurance -- cost paid fully by CONMEDRetirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay periodEmployee Stock Purchase Plan -- allows stock purchases at discounted priceTuition assistance for undergraduate and graduate level coursesKnow someone at CONMED?Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status.If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.