The Quality Assurance Specialist CAPA Investigations Manufacturing manages CAPA investigations for the Alcon JCM Atlanta

a Dailies PVA and other lab and production departments, and ensures that their root cause is identified and closed in a timely manner. Major Accountabilities include: accordance with applicable regulations (e.g., FDA QSRs, ISO13485) and business goals and objectives. Author investigation reports to determine the root causes for nonconformities / deviations / out of specification events, create clear and complete documentation of entire investigation and communicate as appropriate. ns. and timeliness requirements are either met or exceeded. corrective actions. investigations as well as completion of CAPAs on a timely basis, leading to better regulatory compliance. sis reports and submit to management on frequent basis to ensure early detection of potential quality issues. Minimum requirements,Minimum Education Required: BS Degree or equivalent experience. Preferred Level: Bachelors Degree in Physical Sciences or Engineering discipline, ASQ Certification (e.g CQA, CQE, CQM), CAPA certification. Minimum Experience Required: 3+ years in medical device and/or pharmaceutical environment in quality assurance role, Root cause analysis and process improvement training (e.g. FEMA, six sigma) Preferred Level: 5+ years in medical device and/or pharmaceutical environment in quality assurance role Minimum Skills Required: Microsoft Office suite expertise Strong organizational and planning skills Unfaltering attention to detail Preferred Level: Process improvement ability Six Sigma Certification