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Job Profile
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Top Echelon Network
Quality Engineer (2 Poss)
Job Location: Canton, OH
Experience: 3-99 years of experience
Job Summary
Uses Quality Engineering principles, tools and techniques to develop and optimize systems and processes so that they are aligned with the overall Company strategy and mission effecting continuous quality improvement. Coordinates or performs testing to verify equipment and processes comply with all company specifications, QSR, and ISO requirements. Develops and maintains all associated documentation. Assists in process improvement projects and provides technical input and assistance.
General Functions
Support, consult, train and lead quality improvement projects throughout the life cycle of products, including product design and development, manufacturing, and purchasing. Utilize quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits and to assist in specification development. Analyze routine and test data for improvement opportunities. Design and implement experiments (DOEs) for process and product improvement and validation testing. Provides statistical support for sampling plan and analysis, DOEs, Paretos, ANOVA, and SPC applications. Evaluate manufacturing quality performance capability and develop criteria to monitor and improve existing processes.
Investigate instances of nonconforming material and facilitate the determination of root cause, corrective action/preventive action and recommendation of disposition for the material review board. Reviews and/or approves these records for adequacy and compliance to procedures and QSRs. Develop personal performance objectives based upon the facility quality objectives, reporting monthly on progress made against those goals. Has a working knowledge of the quality System Regulation (21 CFR PART 820, including 21CFR806) and ISO 13485 requirements. Periodically serves as back up to QA management. Other duties as assigned.
Qualifications -
To perform this job successfully, an individual must have the technical and managerial competence to be able to perform each essential duty satisfactorily. The requirements listed below are representative of the technical knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Expected Areas of Competence:
Language Skills
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 write procedures and articles for publication conforming to prescribed style and format.
Ability to effectively present information to peers, hourly staff, top management and public groups.
Ability to effectively communicate with all levels of operations.
Project Management Skills
Requires sufficient professional expertise and interpersonal skills to manage multiple projects and interface with personnel from all company disciplines.
Reasoning Ability
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.
Ability to lead, direct and motivate personnel of varied and diverse backgrounds.
Ability to analyze data, make decisions under conditions of stress and implement solutions to problems to facilitate the manufacturing operations.
Ability to work independently to perform responsibilities with minimal supervision.
Education Requirements
Bachelors degree (B.S.) from four-year college or university in a technical discipline candidates with engineering degree will be preferred over other BS degrees must have at least 3.5 GPA minimum 3 years minimum related experience and/or training or equivalent combination of education and experience. Experience in Medical device manufacturing preferred.
Certificates, Licenses and Registrations
A current certification of Certified Quality Engineer (CQE), Black Belt Certification or demonstrated ability to effectively use this core knowledge is required.
Travel Requirements
Minimal
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