Senior CAPA Coordination Specialist - Randstad Life Sciences US : Job Details

Position HighlightsLocation: Hybrid in Durham, NCLength: Minimum 9 months (likely to extend to 1 year)Pay Rate: $70-80/hrInterview Process: 1st Zoom interview, followed by a 2nd round with team membersMust-Have QualificationsCAPA coordination experienceExpertise in QMS supplier quality onboardingAbility to contribute to QMS metricsKnowledge of ISO 13485Auditing experience (useful but not the primary focus)This position will be responsible for the management of QMS and Supplier Quality. This position is accountable for the evaluation, qualification, monitoring, and approval of new and existing suppliers as well as providing guidance to CAPA owners and working closely with CAPA Board Members in the development of CAPA activities and the rigorous assessment of CAPA documentation. This role may also assist with the internal audit program.TASKS AND RESPONSIBILITIES:Provide technical support for activities related to the QMS and Supplier Quality system assessments and performance evaluations.Negotiate and execute Quality Agreements.Assists with metric and data analysis.Responsible for CAPA activities and documentation to assure compliance with CAPA processes.Participates in CAPA Board activity and performs CAPA coordinator rolesLead and Support improvement projects and initiativesReview and coordinate Supplier Change NotificationsIssue and monitor Supplier Corrective Actions.Coordinate and execute supplier and internal audits.Drive and build collaborative working relationships with cross functional teams and suppliers.Supports internal audits and inspections, as needed.Performs other related duties as assigned.QUALIFICATIONS & BACKGROUNDBachelor's Degree in a scientific discipline.Minimum of 5 years of supplier management and auditing experience in a related industry.Knowledge in IVDD/IVDR, ISO 13485, and CAP/CLIA preferred.Effective written and oral communication skills; ability to write, type, express or exchange ideas accurately.Ability to organize and manage multiple projects or tasks.Quality orientation and high attention to detail.Travel may be required (5-10% domestically)