Quality Assurance Coordinator

DescriptionJob SummaryReporting to the Site Quality Manager, the Quality Coordinator is responsible for ensuring that the organization conforms to regulatory requirements, as well as, examining products and materials for defects or deviations from specifications of the Quality Management System (QMS). This is a highly visible position that will require attention to detail and the ability to communicate effectively with all levels of employees across the company.This position is on 1st shift - must be available to work 8 hour shifts and 10 hour shifts, as needed.Essential Job FunctionsDetermines schedules, priorities, and assigns tasks/resourcesTrain employees and contractors on company policies; production procedures and forms; and the use of new equipment, as appropriateDevelop training plans for new employeesMaintain training records of all employeesRead product and package specification drawingsResponsible for writing and/or assisting in the writing of Quality proceduresHelps to perform root cause analysis and corrective actions for quality related issuesGenerates device history file (batch record file)Accepts or rejects finished itemsCompletes non-conformances on products and materials that fail to meet specificationsMaintain calibrations and preventive maintenance systemsReview proofs of artwork prior to literature being printed for productionInvolved with all aspects of the work order processChange control in MasterControlCreate UDI labels for new products and update current labels according to any changes neededMaintains quality service by establishing and enforcing organization standardsPerform duties as back-up to the Quality InspectorsCompletes certificates for finished goods per customer requirementsOversee returns from customersOther duties as assignedRequirementsQualificationsUndergraduate diploma and minimum two (2) years of experience working in medical device manufacturing or related field in a team environmentOne (1+) year(s) in a Quality Control or Quality Assurance position with a medical device manufacturer or related fieldWorking knowledge of cGMP and cGDP, as well as FDA and ISO standards is a plusKnowledge of testing equipment, statistical methods, and control plansComputer skills including Microsoft Word, Excel, and PowerpointKnowledge of ERP systems (e.g., Microsoft 365, SAP, etc.)Able to work well independently and detailed orientedStrong interpersonal skills with the ability to deal effectively, and respectfully, with a variety of personnelAble to read and interpret documents such as safety rules, standard operating procedures (SOPs), work process aids, company policies, and instruction manualsAble to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.Able to apply common sense understanding to carry out instructions furnished in written, oral, or diagram formAble to compute rate, ratio, and percentAble to operate a pallet jackSupervisory ResponsibilitiesThe Quality Coordinator may have to perform supervisory responsibilities at times, in accordance with the organization’s policies and applicable laws. Responsibilities may include interviewing and training employees, planning, assigning, and directing work.Physical RequirementsPerforming the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping, reaching, lifting, carrying, bending/stooping, kneeling/crawling, climbing, balancing, pushing/pulling, vision requirements - close vision.Mental RequirementsThis position requires the ability to maintain an appropriate work pace, comprehend and follow instructions, exercise logic and reasoning, organize and prioritize, read, compose written communication, communicate verbally, problem solve, count, and compute, and multi-task/re-direct. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations.Other RequirementsThe employee must be trained on all the documents, procedures, software applications and topics listed in the Training Matrix. Documentation of this training will be maintained with Human Resources. Additional training requirements may be added as deemed necessary by the supervisor.Work EnvironmentThe noise level in the work environment is usually quiet to moderate.