Job Details

Job Title: Quality Analyst (Medical Devices) Duration: 1+ year contract Responsibilities Lead timely investigations of product and process nonconformance events; collect evidence, interview stakeholders, and document findings to create clear, complete NCRs.Perform root cause analysis using structured tools (5 Whys, fishbone, Pareto) and recommend containment, correction, and corrective/preventive actions in partnership with Quality and Operations.Prepare concise, audit-ready reports; maintain accurate records within the Quality Management System (QMS) to ensure traceability and data integrity.Monitor trends and metrics, support risk assessments, and contribute to continuous improvement initiatives using Lean and Six Sigma principles.Support Quality Inspection, as neededThe list of duties and responsibilities is not exhaustive and may include and/or be substituted as necessary with other tasks as defined by management.Education Bachelor's degree in engineering, life sciences, quality, or a related field; or equivalent practical experience.Experience 3+ years in manufacturing or quality, preferably in a medical device or other regulated environment.Preferred qualifications Working knowledge of ISO standards relevant to medical devices (e.g., ISO 13485), 21 CFR 820, Good Manufacturing Practice (GMP), and Total Quality Management (TQM).Hands-on experience with Corrective and Preventive Action (CAPA), nonconformance workflows, and electronic QMS platforms.Six Sigma Green Belt or equivalent; proficiency with data analysis tools such as Excel or Minitab.#J-18808-Ljbffr