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Quality Engineer II

  • Anywhere

Company :
CareFusion

Location :
Mebane, North Carolina

Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT

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Description :
Job Description SummaryThis position is responsible for working as part of the Quality team at the Mebane manufacturing plant. Activities will include, but are not limited to: equipment installation support, equipment and process validation support, processing and investigating complaints, risk management documentation, investigating product/process nonconformities, providing production QE support, defining and implementing process metrics, gathering and presentation of metrics, and documentation creation and revision. The Quality Engineer functions as a quality subject-matter resource to support Engineering, Operations, and issue investigation. Job Description Essential Job Functions Represents the company in a professional manner. Provides support to Production, Engineering, Project Teams and Quality Department. Working within the Quality Engineering team to: – Assist Production and Engineering in production process development, equipment installation and validation – Process and environmental monitoring environmental and steam sterilization – Drive and assist nonconformity investigation and processing – Completion of assigned activies within a timely fashion – Create, review and approve Quality System Documents (CAPA, Audits, procedures, work instruction, product non-conformancies). – Develops and maintains a working knowledge of BD policies, procedures and regulatory requirements – Ensures operation is complaint to established procedures – Maintains accurate data, analyzes and summarizes conclusions drawn from investigation and product analysis – Performs tasks accurately and with great attention to detail. Interfaces with manufacturing, engineering, product support and divisional groups. Basic Qualifications – Ability to perform quality engineering work of a broad nature with little or no direction from Quality Management. – Basic knowledge of medical device regulations, industry or international standards. – Basic knowledge of steam sterilization – Basic knowledge of environmental monitoring – Basic knowledge of Risk Management standards and application. – Basic knowledge of manufacturing processes. – Basic knowledge of root cause investigation methodologies. – Excellent communication skills (verbal, written, and presentation). – Understands how to present information dependent upon the level of the audience. – Understands Fundamentals of Quality Engineering Principles. – Ability to effectively manage time and manage priorities to meet deadlines. – Ability to handle multiple task assignments. – Ability to interpret Corporate, Division and Department Procedures. – Ability to work with minimal supervision. – Ability to work in a team. Job Dimensions: The role requires excellent communication skills, the ability to effectively interact with all levels of associates and functional departments in the organization including external customers and a strong understanding of quality engineering principles. Education and Experience Required: Bachelor’s degree in science, engineering, manufacturing technology or closely related field with minimum 3 years experience in Quality Assurance or Quality Engineering. OR 7-10 years of relevant experience in lieu of degree. Excellent attention to detail. Working knowledge of medical device manufacturing regulations and standards. (i.e.: FDA 21CFR820, ISO 13485, ISO 14791, etc) Must be proactive and have strong interpersonal and project management skills. Ability to work both independently and in partnership with others. Proven ability to use initiative and drive to achieve results. Education and Experience Preferred: Experience in steam sterilization validation Experience in process and equipment validations Experience in product non-conformance processing Experience in risk management requirements and documentation. Cytotechnologist degree, certification or training Six Sigma Black Belt Certification preferred American Society of Quality (ASQ) certification (CQE, CQA, etc) Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. Primary Work LocationUSA NC – Mebane Additional LocationsUSA NC – Research Triangle Park Work Shift