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Quality Engineer II

Location: Rockville
Posted on: February 17, 2021

Job Description:

POSITION SUMMARY:The Quality Engineer II is responsible for planning and directing activities concerned with development, application and maintenance of quality standards for processes, materials and products in accordance with quality programs, plans, SOPs and policies of the company's Quality System. This position is also responsible for ensuring compliance with corporate policies, FDA regulations, ISO 13485:2003 and other regulatory requirements, as applicable. DUTIES AND RESPONSIBILITIES: --- Development and Implementationo Direct quality system improvement projects under the direction of the QA Director and assist in implementation of quality standards throughout the companyo Provide mentoring to employees throughout the company regarding industry best practices for ISO compliance and future cGMP complianceo Assist in development, implementation and maintenance of a Quality System compliant with cGMPs, ISO and International regulationso Participate in departmental meetings to provide input into the design and implementation of product quality planning systems and procedures--- External Audit Supporto Assist with FDA inspections, ISO audits and customer auditso Follow up on corrective action responses for external audits, ensuring implementation of appropriate problem resolution methods and verifying effectiveness --- Cross Functional Collaborationo Interface with other departments on continuous improvement of the Quality Systemo Facilitate problem solving activity through Total Quality Management (TQM), team building and quality systems tools and methods--- Validation Supporto Serve as Quality Assurance representative on validation activities (e.g. equipment, process, assay, spreadsheet, software, facilities and utilities)--- Write, review and edit documents (SOPs, validation protocols, technical reports)--- Review and approve change orders as designee for QA Director--- Partner with requestors, Purchasing, QA auditing group and other departments as needed to ensure timely completion of new supplier requests/changes to existing suppliers and implementation of these changes to the approved supplier list--- Provide leadership within assigned areas of responsibility--- Specific duties may vary depending upon departmental requirementsEXPERIENCE AND QUALIFICATIONS:--- Bachelor's degree or Master's degree in a technical/scientific/engineering discipline is requiredo If Bachelor's degree, minimum 7 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or related industry is required o If Master's degree, minimum 3 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or related industry is required --- Experience planning and implementing quality plans and programs--- Minimum of 5 years of work experience with FDA's Quality System Requirements (QSR), ISO 9001 and ISO 13485:2003 standards is required--- Computer literateo Proficient in MS Office Suiteo Knowledge of MasterControl is beneficialo Capacity to learn additional software applications as the need arises --- ASQ Certified (CQE, CRE) is beneficial --- A demonstrated level of consistency in performance and aptitude for managing additional responsibility and accountability are required for next level considerationKNOWLEDGE, SKILLS AND ABILITIES:--- Strong quality fundamentals and analytical background o Logical problem solving through TQM, team building and quality systems tools and methodso Demonstrated ability to organize and move project tasks forward in an orderly and structured fashiono Working knowledge of cGMP, ISO and International regulations o Experience with developing, implementing and maintaining Quality System compliance --- Excellent oral, written communication and interpersonal skills o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data--- A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in demanding manufacturing and research environments with changing prioritiesPHYSICAL DEMANDS:This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office.WORK ENVIRONMENT:This position is performed in a standard office environment.

Keywords: MESO SCALE DIAGNOSTICS, LLC., Rockville , Quality Engineer II, Engineering , Rockville, Maryland

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