QA Specialist II (Medical Device)

Pay Rate Low: 35 | Pay Rate High: 45Quality Assurance Specialist IILocation: downtown Houston, TX (Onsite)Duration: 9–12+ month contract assignmentPay Rate: $35–$45/hr (based on experience)Industry: Life Sciences / Medical Device / BiotechOverviewA leading life sciences organization is seeking a Quality Assurance Specialist II to support and enhance core Quality Management System (QMS) processes. This contract role will play a key part in maintaining quality compliance, driving continuous improvement initiatives, and supporting cross-functional quality programs across operations.This individual will work closely with Quality leadership and internal stakeholders to strengthen quality systems, improve compliance readiness, and support risk mitigation across the organization.Key ResponsibilitiesProvide Quality oversight and support for manufacturing and operational activitiesReview and approve production lots to ensure compliance with specifications and proceduresTrack, trend, and analyze quality data to identify risks and improvement opportunitiesDrive continuous improvement through metrics, investigations, and process monitoringSupport and lead Quality System processes including deviations, CAPA, and change controlMaintain and improve Document Control processes within an electronic QMSSupport supplier qualification and vendor quality programsParticipate in validation review activities (equipment, systems, process changes)Assist with audit readiness, hosting, and remediation activitiesGenerate quality metrics and communicate compliance risks to stakeholdersDevelop and deliver QMS training across the organizationMentor junior team members and help foster a strong culture of qualityQuality Systems Ownership AreasProduction lot release and record reviewDeviations, nonconformances, and CAPA investigationsChange management and controlled implementationSupplier qualification and quality agreementsValidation and qualification reviewDocument control and SOP lifecycle managementQuality metrics trending and reportingAudit preparation and compliance trackingQualificationsEducation:Bachelor’s degree required (Engineering, Biology, Chemistry, Statistics, or related field preferred) OR equivalent combination of education and 6–8+ years of relevant experienceExperience & SkillsStrong working knowledge of Quality Management Systems within regulated environmentsExperience supporting FDA and/or ISO-regulated industriesHands-on experience with deviations, CAPA, change control, and investigationsExperience with document control and electronic QMS platforms (e.g., MasterControl preferred)Knowledge of statistical analysis tools (Minitab, R, etc.) preferredStrong technical writing and investigation skillsFamiliarity with biological or analytical lab environments is a plusRegulatory Experience (Preferred)Experience supporting one or more of the following:FDA (21 CFR 820, cGMP, cGTP)ISO 13485, ISO 9001ISO 15189 / ISO 17025Medical device, diagnostics, or life sciences manufacturingINDBH