ConMed Electrosurgery, a medical equipment manufacturer and marketer of electrosurgical equipment and disposable products, has an immediate opening for a Sr. Quality Engineer.
Description of Duties/Qualifications
ConMed Electrosurgery is a leading medical device manufacturer of state-of-the-art electrosurgical generators, handpieces, smoke management systems, and accessories. We deliver surgical solutions to surgeons and their patients around the world. If you have a strong work ethic and enjoy a fast-paced environment, we would like to invite you to apply for our Senior Quality Engineer position at our Centennial, CO facility.
Description of Duties:
To provide Quality Engineering support to all functions for the design, procurement, assembly, test, manufacturing, validation, and distribution of medical devices, processes, and quality systems. Provide guidance to other quality engineers in department.
â¢ Develop, Implement, and maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements.(EN ISO 13485/CMDCAS/MDD & FDA QSR) Keep current on all applicable best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices.
â¢ Perform quality system audit planning, preparation, execution, reporting results, and follow-up.
â¢ Develop and implement quality programs, including tracking, analyzing, reporting, problem solving. Acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.
â¢ Support supplier development through supplier capability assessment, analyzing performance data, facilitating problem-solving activities, developing suppliers in quality tools and techniques. Auditing and qualifying new suppliers, working with Purchasing on supplier selection for new programs, driving VA/VE efforts with supply base, solving process and design problems with suppliers, and ensuring supplier advance quality planning during program development phase.
â¢ Review and approve engineering designs/changes for adequate quality, reliability, maintainability, and risk management, modeling, systems design, assessment tools, reporting and manufacturability.
â¢ Investigates process and product issues identified through complaints and trend analysis of other conformance data. Works with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations. Direct and facilitate investigations and resolution of validation failures, process deviations, abnormal results, complaints and quality inquiries and other quality performance indicators.
â¢ Plans, controls, and assures product and process quality which include planning processes, material control, acceptance sampling, and measurement systems. Assists in the development and implementation of product and process quality plans and inspection and testing strategies. Provides support for the development and implementation of process validations and equipment qualifications.
â¢ Lead the product development teams in completing hazard and risk management documentation. Develops and implements product quality plans, documents and systems by creating quality specifications and quality plans in conjunction with other product development team members. Will provide input on test methods and protocols to ensure testing is adequate and sample size appropriate for the safety and efficacy of the device.
â¢ Provides input on as well as creates/develops test methods and protocols to ensure material and product verification activity is adequate to assure the safety and efficacy of the device. Additionally these will ensure the completion of necessary design verification and validation activity including biocompatibility, sterilization validations, and product shelf life testing on new devices for product development teams.
â¢ Bachelorâs degree in an engineering or scientific discipline with 5+ years of medical device experience.
â¢ 7-10 years experience in medical, mechanical or electrical production, test, or inspection is required with a high level of analytical and problem solving skills.
â¢ Fundamental understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.
â¢ Thorough understanding of problem solving and quality improvement tools /techniques, metrology, SPC, FMEAS, Control Plans, DOE and capability studies. This includes knowledge of management and planning tools, quality tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
â¢ Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
â¢ Ability to write reports, business correspondence, and procedure manuals.
â¢ Ability to effectively present information and respond to questions.
â¢ Visit our website. http://www.conmed.com/conmed_employment_menu.php
â¢ Candidates without Internet access or requesting reasonable accommodation for a disability may complete an online application in person at 14603 E. Fremont Ave., Centennial, CO between 8:00 am and 3:30 pm, Monday through Friday.
ConMed Electrosurgery is an EEO, AAP, and E-Verify Employer.
Conmed Corporation - 2 years ago
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