Medical Device Quality Engineer

Job Title: Medical Device Quality EngineerLocation: Madison, WIPay Rate : $40--45/hr on W2Schedule: Onsite, Monday–Friday (standard business hours)SummaryThe Senior Quality Analyst/Engineer is responsible for ensuring compliance and maintaining strong Quality Systems for the Madison facility. This role oversees CAPA, Change Management, investigations, deviations, Quality Management Reviews, audit coordination, and facility-wide quality metrics. The position supports Quality System improvement initiatives, data trending, reporting, audits, and cross-functional collaboration with Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management to strengthen quality culture.Principal ResponsibilitiesDevelop and maintain Quality System processes, including metrics reporting and trackingManage CAPA initiation, review, surveillance, and reportingFacilitate site Quality Management ReviewsLead and coordinate the site Change Management processSupport and lead root cause analysis through cross-functional teamsLead Good Documentation Practice (GDP) training and Quality on the Floor activitiesInterpret and apply all applicable regulatory requirementsCoordinate and support facility audits by internal and external agenciesManage data collection and reporting for product recallsPerform Quality System trending to support FDA and Management reviewsDrive quality culture through site initiatives and procedure improvementsReview and approve procedures, protocols, and reports as requiredAdditional/Non-Essential ResponsibilitiesDocumentation filing and management as neededSupport other Quality System functionsMay be required to lead personnel within or outside the Quality organizationMinimum RequirementsEducation & Experience:Bachelor’s degree (or higher) in a science or technology field preferred5+ years of Quality Assurance experience in a cGMP-regulated environment (medical device experience preferred)Skills & CompetenciesStrong communication, coaching/mentoring, and presentation skillsAbility to manage change effectivelySelf-motivated with strong decision-making abilitiesProject management skills with a track record of on-time deliveryLeadership and emotional intelligenceModerate proficiency in statistics for data trending and interpretationTechnical CompetenciesProficient in Microsoft Excel, Word, and PowerPointStrong technical writing skillsExperience with statistical analysis software (e.g., Minitab preferred)Organizational Relationship / ScopeThis role collaborates closely with Manufacturing, Quality Control, Engineering, Facilities, Materials Management, Regulatory Affairs, and Process Development. Must thrive in a fast-paced environment with strict timelines. Primarily onsite Monday–Friday, with occasional extended hours, weekends, or holidays to support business needs.Working ConditionsThe Senior Quality Analyst will primarily work in an office setting. Limited domestic and international travel may be required.