Facilitate and continually improve complaint handling system. Perform and coordinate investigations of product returns in a timely manner. Review and approve release of or changes to specifications and drawings, evaluating design change impact, including effect on inspection, verification/validation, risk analysis, sterilization, and biocompatibility Identify areas requiring corrective and preventive action, including those resulting from product. Coordinate activities associated with planning and implementing solutions. Follow up, as required, to ensure effective implementation Provide data collection, review, and analysis of processes supporting production and product quality. Communicate information effectively Quality representative for Material Review Board (MRB) activities. Corrective and Preventive Action Assist in maintenance of CAPA Log or database and coordination of CAPA Review Board meetings Complete assigned CAPA actions Conduct and document verification of implementation and effectiveness of corrective and/or preventive actions Support and participate in inspection and test activities. Review and approve inspection requirements Assist in inspection processes through development of inspection tools and aides; i.e., go/no go gages, visual standards, and reference samples Review and approve first article inspections Determine compliance to specifications. Support Spiration quality management system Perform or assist in hosting internal audits according to approved schedule. Maintain SPC database and expand implementation, as needed. Create/revise SOPs and work instructions. Sterilization and Biocompatibility Assist in coordinating the development of sterilization processes, validation, revalidation, and routine monitoring. Review sterilization test results for final product release. This includes, but is not limited to, EO residuals, sterility, and bacterial endotoxins (pyrogen). Assist in determining applicable biocompatibility requirements for US and international compliance. Coordinate biocompatibility testing with outside laboratories. Trend analysis and data reporting for identified performance measures. MINIMUM QUALIFICATIONS (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the, education, knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) EDUCATION Evidence of continued learning efforts a plus. BS degree in a technical discipline is required. EXPERIENCE 2++ years a in medical device manufacturing environment. Previous Quality Engineering experience preferred.
Facilitate and continually improve complaint handling system. Perform and coordinate investigations of product returns in a timely manner. Review and approve release of or changes to specifications and drawings, evaluating design change impact, including effect on inspection, verification/validation, risk analysis, sterilization, and biocompatibility Identify areas requiring corrective and preventive action, including those resulting from product. Coordinate activities associated with planning and implementing solutions. Follow up, as required, to ensure effective implementation Provide data collection, review, and analysis of processes supporting production and product quality. Communicate information effectively Quality representative for Material Review Board (MRB) activities. Corrective and Preventive Action Assist in maintenance of CAPA Log or database and coordination of CAPA Review Board meetings Complete assigned CAPA actions Conduct and document verification of implementation and effectiveness of corrective and/or preventive actions Support and participate in inspection and test activities. Review and approve inspection requirements Assist in inspection processes through development of inspection tools and aides; i.e., go/no go gages, visual standards, and reference samples Review and approve first article inspections Determine compliance to specifications. Support Spiration quality management system Perform or assist in hosting internal audits according to approved schedule. Maintain SPC database and expand implementation, as needed. Create/revise SOPs and work instructions. Sterilization and Biocompatibility Assist in coordinating the development of sterilization processes, validation, revalidation, and routine monitoring. Review sterilization test results for final product release. This includes, but is not limited to, EO residuals, sterility, and bacterial endotoxins (pyrogen). Assist in determining applicable biocompatibility requirements for US and international compliance. Coordinate biocompatibility testing with outside laboratories. Trend analysis and data reporting for identified performance measures. MINIMUM QUALIFICATIONS (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the, education, knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) EDUCATION BS degree in a technical discipline is required. Evidence of continued learning efforts a plus. EXPERIENCE 2++ years in a medical device manufacturing environment. Previous Quality Engineering experience preferred.
Quality%20Engineer.140927_2.docx