Quality Engineer I
On-site
Job Description
We are seeking a self-driven and continuous improvement-focused Quality Engineer I to join our Utica, NY based Quality Engineering team. In this role, you will work cross-functionally to provide support to all functions for the design, procurement, assembly, test, manufacturing, validation, and distribution of medical devices, processes, and quality systems. This role will be supporting the supplier quality and processes. At CONMED, we do things the right way. Our Quality Engineering team comprises passionate engineers and specialists who maintain programs and systems that ensure adherence to quality standards and expectations. This team's work is crucial in ensuring that our products are accessible to our healthcare customers around the world. This is an onsite position in Utica, NY.
Responsibilities
· Investigate process and product issues as assigned by supervisor. Work with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations.
· Assist in the development and implementation of product and process quality plans and inspection and testing strategies. Provide support for the implementation of process and product qualifications and validations.
· Assist in the development and implementation of quality programs, including analyzing and problem solving including proposing solutions/improvements as well as execution of these proposals.
· Assist in the day-to-day operations of the Corrective and Preventive Actions system and assist in the implementation and effectively determination of corrective and preventive action plans.
· Provide direction on test methods and protocols to ensure verification activity is adequate to assure the safety and efficacy of the device for product development and quality conformance teams.
· Assist in the performance of supplier capability assessments, analyzing performance data, facilitating problem-solving activities, and developing suppliers in quality tools and techniques. Auditing and qualifying new suppliers, performing VA/VE efforts with and solving process and design problems with suppliers.
· Assist product development teams. Develop and implement product quality plans, verification/validation protocols and reports and other documents and systems by creating quality specifications and quality plans in conjunction with other product development team members.
· Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements.
· Perform investigations and resolution of validation failures, process deviations, abnormal results, complaints and quality inquiries and other quality performance indicators as applicable.
· The Quality Engineer is responsible for analysis and decision making that has major impact on system and product compliance and the organization’s ability to meet customer and regulatory requirements.
Job Requirements
Requirements:
· Bachelor’s degree
· 0-2 years of experience in medical, mechanical or electrical production, test, or inspection environment
Preferred Experience:
· Basic understanding of problem solving and quality improvement tools and techniques.
Travel Expectations 0-20%
This position is not eligible for employer-visa sponsorship.
