Help maintain adherence to quality system requirements to internal policies andexternal regulations (ISO 13485, 21CFR 820, 21CFR 11, OSHA, etc.).Monitor the production operations through coordination of production/quality audits.Supervise a team of 22 quality inspectors covering several medical device manufacturing lines. Fulfill the necessary daily responsibilities of supervising personnel with hiring/firing authority, and the ability to promote exceptional team members within… Show more Help maintain adherence to quality system requirements to internal policies andexternal regulations (ISO 13485, 21CFR 820, 21CFR 11, OSHA, etc.).Monitor the production operations through coordination of production/quality audits.Supervise a team of 22 quality inspectors covering several medical device manufacturing lines. Fulfill the necessary daily responsibilities of supervising personnel with hiring/firing authority, and the ability to promote exceptional team members within the (quality assurance) inspector career levels. Perform gap analyses of visual inspections to ensure compliance to all manufacturing/quality procedures. Aid in the processing of non-routine and routine nonconforming product. Manage and help in training personnel with multiple controlled documents pertinent to the production floor. Coordinate with differing production areas to standardize process audit procedures on a site wide basis. Expedite documentation repairs to minimize production downtime. Investigate internal audit findings to a root cause level and develop implementation strategies for their correctives. Restructure and create inspector training plans to assist with the introduction of new technologies. Give feedback to employees on/and monitor performance on a daily basis.Schedule personnel/inspectors to meet production needs and assist in hiring decisionsfor new personnel.Maintain and conduct training and certification activities as required.Interact with Manufacturing Operations team and Engineering team members regardingMRB review, identification and resolution of production floor defects and/or productproblems.Actively participate in investigations related to process deviations, non-conformancesand customer complaints.Provide feedback in evaluating, prioritizing, and implementing lean manufacturingmethods, processes and flow to meet continuous improvement goals. Show less

Help maintain adherence to quality system requirements to internal policies andexternal regulations (ISO 13485, 21CFR 820, 21CFR 11, OSHA, etc.).Monitor the production operations through coordination of production/quality audits.Act as quality lead for determining routine/nonroutineconformance defects, andmaintain maintenance/review of documentation.Assist quality manager in department goals/expectations, providing performancefeedback to employees, and monitor… Show more Help maintain adherence to quality system requirements to internal policies andexternal regulations (ISO 13485, 21CFR 820, 21CFR 11, OSHA, etc.).Monitor the production operations through coordination of production/quality audits.Act as quality lead for determining routine/nonroutineconformance defects, andmaintain maintenance/review of documentation.Assist quality manager in department goals/expectations, providing performancefeedback to employees, and monitor performance on a daily basis.Schedule personnel/inspectors to meet production needs and assist in hiring decisionsfor new personnel.Maintain and conduct training and certification activities as required.Interact with Manufacturing Operations team and Engineering team members regardingMRB review, identification and resolution of production floor defects and/or productproblems.Actively participate in investigations related to process deviations, nonconformancesand customer complaints.Provide feedback in evaluating, prioritizing, and implementing Lean manufacturingmethods, processes and flow to meet continuous improvement goals. Show less

Monitor the visual acceptance of final product at completion according to final checkliststandard/criteria.Investigated production related QA problems and make recommendations.Verification to validate material is in spec to visual acceptance and functionalityrequirements used for its intended purpose on the correct product.Help individuals performing activities affecting FIT and Function of the product tounderstand WHY something is not right when process and/or… Show more Monitor the visual acceptance of final product at completion according to final checkliststandard/criteria.Investigated production related QA problems and make recommendations.Verification to validate material is in spec to visual acceptance and functionalityrequirements used for its intended purpose on the correct product.Help individuals performing activities affecting FIT and Function of the product tounderstand WHY something is not right when process and/or productnon-conformancesare identified.Notify supervisor of unusual problems, delays, and/or safety issues. Show less