Quality Engineer

CAPA Engineer Bloomington, Indiana- onsite Contract on W2 USC and Greencard Job Summary The CAPA Leader executes within the CAPA process to ensure the adequate resolution of quality and/or compliance issues related to the operations and quality management systems. C: Reporting Relationships and Organizational Impact Reports To: Quality Engineering Manager Manager Role: Non-Manager Regular interaction with departments, employees and management at all levels. D: Qualifications Education: Bachelor's degree in a technical field. Preferred: ASQ/RAB certifications, Six Sigma Green Belt. Experience: 3+ years in quality assurance/engineering and project management. Knowledge: CAPA process, ISO 13485, ISO 14971, 21 CFR 820. Skills: Microsoft Office, communication, teamwork. E: Duties and Responsibilities Manage CAPA program, schedule and facilitate CAPA meetings, track action items, oversee CAPA implementation, ensure documentation completeness, provide metrics, support audits, and improve CAPA processes. F-I: Physical Requirements, Hazards, Lifting and Disclaimer Office setting. Sedentary work. Compliance with company policies required. Overview Hiring for a fully on-site CAPA engineer (tier 4) to reduce an unprecedentedly high number of CAPAs after two audits this year (the second audit produced 6 findings). Role requires minimum 3 years CAPA management experience, knowledge of ISO 13485 / FDA QSR (Part 820), strong technical writing and meeting leadership; plastics/medical-device background is a plus. Preferred tools: Microsoft Office suite; TrackWise and Visio are nice-to-haves; emphasis on clear, technical written communication. Hiring need & reason Team experienced two audits this year, which is atypical, and the second audit produced 6 findings, driving an increased CAPA backlog. The business needs someone who can reduce CAPA volume quickly and manage CAPA projects end-to-end. Goal is to onboard a contractor who can hit the ground running and lead CAPA investigations and write-ups immediately. Expected outcome: lower CAPA backlog and improved CAPA execution cadence. Role, level, and experience Position is not managerial; it's an engineer-level role responsible for executing and leading CAPA projects from initiation to closure. Minimum requirements 3 years explicit CAPA management/lead experience and a bachelor's in engineering or related field. Desired: technical expertise, ideally medical-device experience and familiarity with plastics manufacturing (extrusion, injection molding, over-molding) as a plus. Regulatory & quality expectations Candidate must be comfortable with ISO 13485 and associated FDA QSR expectations (FDA updated QSR to reference ISO 13485). Many CAPAs will be quality-systems-related; knowledge of 13485-aligned processes and documentation expectations is important. Interview should assess candidate ability to convey a clear, technical understanding and to write technically correct CAPA documentation. Day-to-day activities Typical day: investigating processes, coordinating with subject-matter experts, conducting root-cause analysis, and producing CAPA write-ups. Role requires strong meeting leadership, ability to coordinate stakeholders, collect information, and drive investigation outcomes. Consistency expected in CAPA investigation methodology and clear, succinct written outputs. Tools & skills Must be proficient with Microsoft Office (Excel, PowerPoint, Outlook); TrackWise experience is a nice-to-have. Visio experience is helpful for process flow documentation and CAPA investigations, listed as a nice-to-have. Strong technical writing, professional communication, and concise interview responses are critical evaluation criteria. #J-18808-Ljbffr