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Quality System Specialist

Company: National Coalition of Healthcare Recruiters
Location: Atlanta
Posted on: July 13, 2018

Job Description:

(Only QUALIFIED Healthcare Professionals accepted) Medical Technologist - Quality System SpecialistOverview:We are seeking a results-oriented and experienced Quality System Specialist to join our team. In this position, you will play a key role reviewing all Device history record documentation to ensure compliance to all applicable regulatory standards. This will involve using your detail-oriented abilities and knowledge of standard concepts, practices and procedures to provide quality input. If you have a solid background working in a comparable manufacturing environment, and the analytical capabilities that this position requires, we look forward to hearing from you. Our company is a global leader in transfusion and transplantation diagnostics that facilitate patient-donor compatibility worldwide. Quality Assurance System Specialist (Manufacturing Compliance - Systems QA) Responsibilities: As a Quality System Specialist, you will be responsible for reviewing and approving al documentation for serological, chemical and biological evaluations to ensure product meets specifications prior to distribution. This will include evaluations completed on final, intermediate and raw material products and for filling, labeling and packaging operations. Specific duties for this manufacturing operations compliance role include, but are not limited to: Performing batch record review, product disposition and quality issue resolution to maintain the flow of products and documents to meet site objectivesEnsuring accuracy, integrity and completion of every page, reconciliation, and product yield computationIdentifying mistakes, oversights, and incomplete data on batch records and reporting batch record deficiencies to Manufacturing for correctionUnderstanding regulatory requirements thoroughly, including domestic and international standards applicable to our company and the consequences of nonconformanceWriting, standard operating procedures, change orders, document change requests, and corrective-preventive action requestsMaintaining a thorough understanding of our company policies and basic understanding of activities of all company departmentsRepresenting our Sr. Quality Operations Managers and- or Quality Operation Managers in a variety of forums, as deemed necessaryEfficiently making quality decisions, to include determination of a quality deviation, Product hold and disposition, etc. based on the specific circumstances that could affect product qualityQuality Assurance System Specialist (Manufacturing Compliance - Systems QA) Qualifications: We are looking for a highly organized and detail-oriented Quality System Specialist who combines exceptional analytical and problem-solving skills with the ability to quickly drive solutions while maintaining positive relationships. In addition, you should be able to work independently to manage and prioritize workload and assignments within a fast-paced manufacturing environment. It is also vital to this role that you display excellent verbal and written communication skills, as well as the ability to effectively build working relationships both internally and externally at various organizational levels of the organization.Specific qualifications for this medical device quality assurance role include:Bachelors degree in a related scientific field5+ years of experience in a comparable manufacturing environment to ensure sound judgment and performanceComputer proficiency including, MS Office SuiteIntermediate mathematics skillsKnowledge of quality assurance practices within the medical device industry, including FDA Quality System Requirements (QSR) and ISO 13485, as well as Canadian Medical Devices Regulations, and In Vitro Diagnostics DirectiveAbility to adhere to Regulatory and Compliance Standard operating proceduresExperience and-or certification as a medical technologist, preferred

Keywords: National Coalition of Healthcare Recruiters, Atlanta, Quality System Specialist, Other, Atlanta, Georgia

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