West Palm Beach, FL30+ days ago
Experience with quality systems; Complaint Handling, MDR reporting, CAPA, Non-Conformance, Change ControlSkills:Project Leadership: Strong ability to lead complex, cross-functional initiatives and drive results across multiple stakeholdersAnalytical & Problem-Solving: Expertise in root cause analysis, data trending, and risk-based decision makingRegulatory Interpretation: Ability to interpret and apply FDA and ISO requirements to practical business processesCommunication & Influence: Effective verbal and written communication; ability to influence without direct authorityProcess Improvement: Demonstrated ability to identify inefficiencies and implement sustainable improvementsAttention to Detail: High level of accuracy in documentation, compliance, and data analysisCollaboration: Strong interpersonal skills with experience working across Quality, Engineering, Operations, IT, and external partnersOrganizational & Time Management: Ability to manage multiple projects and priorities simultaneouslyEducation:Bachelor's degree (required)Bachelor's degree in a scientific field, i.e. engineering (Preferred)Lean Six Sigma, Project Management (Preferred)58911Quest Diagnostics honors our service members and encourages veterans to apply. Post-Market Surveillance Oversee complaint handling processes in compliance with 21 CFR 820.198.Perform and/or approve MDR reportability assessments in accordance with 21 CFR Part 803.Lead and coordinate corrections and removals (recalls), including supplier-related events, per 21 CFR Part 806.Ensure complete, accurate, and inspection-ready documentation for all post-market activities.