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Quality Specialist
Contract : Louisville, Kentucky, US
Salary Range : 40.00 - 50.00 | Per Hour
Job Code : 358374
End Date : 2025-03-06
Days Left : 25 days, 2 hours left
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Position Details :
Industry Medical Devices
Job Title Quality Systems Spec
Work Location Louisville, KY - 40219
Duration 2 Months
Pay Range $40-50 / hr
Must Have : Regulatory Knowledge - FDA 21 CFR, ISO 13485
Nice To Have :
Knowledge Inventory Management Systemquality auditing experienceHM's Top Needs :
Experience working in Quality for minimum 2 yearsExperience with CAPA, Root Cause Analysis tools and AuditingAbility to work independently since this person will be at a 3PL site as the MDT quality rep.Education Required : Bachelor's
Years' Experience Required : 2
Job Responsibilities :
Responsibilities may include the following and other duties may be assigned.Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.Provides expertise and guidance in interpreting policies, regulatory and / or governmental regulations, and agency guidelines to assure compliance.Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.Coordinates legal requests in support of government investigations or litigations.Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.Specialist Career Stream :
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and / or manages projects assigned and works with other stakeholders to achieve desired results.May act as a mentor to colleagues or may direct the work of other lower level professionals.The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).Differentiating Factors :
Autonomy : Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.Organizational Impact : Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.Innovation and Complexity : Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.Communication and Influence : Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making.Leadership and Talent Management : May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.Required Knowledge and Experience :
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.Job Requirement
quality systemRegulatoryRoot cause analysisquality auditingReach Out to a Recruiter
RecruiterEmailPhoneSrividhya Msrividhya.m@collabera.com9733817228Apply Now
Salary : $40 - $50
