Lead Auditor (Iso9001 And Iso13485 Medical Experience Required)

Fedex Memphis , TN 38103

Posted 2 months ago

Company: FedEx Logistics Job Title:

Lead Auditor (ISO9001 and ISO13485 medical experience required) Job Requisition Number: RC362697 Time Type: Full Time Job Type:

Regular Primary Job Posting Location: 145 Lt George W. Lee Memphis, Tennessee 38103 United States Posting Date: 2021-07-27 Job Posting End Date: 2021-07-30 The Lead Auditor will lead and facilitate audits and audit teams at multiple facilities in support of facility certifications, new business implementation and quality risk based audits. Perform internal audits, by leading an audit team or as a solo auditor, at multiple facilities (travel in the 40-50% range). Support new startup businesses by performing pre and post start up reviews.

Monitor changes within International Organization for Standardization (ISO) and other quality standards to ensure current methods, practices and procedures are kept current. Communicate and coordinate with registrars and facilities to schedule audits and resolve findings. Generate formal audit reports and supporting evidence of results.

Effectively communicate audit results to all levels of management. Ensure quality audit metrics are adequately captured, analyzed and communicated. Use the results of Audit to identify opportunities for improvement for all Quality Management System (QMS) processes.

Manage and monitor nonconformities with respect to the QMS Procedure. Provide guidance and assistance on creation and implementation of Corrective and Preventive Action (CAPA's). Monitor the effectiveness of the Corrective/Preventive action process and conformance to the QMS Procedures driving timely and effective completion. Coordinate with regulatory department on facility requirements.

Provide Quality project support using FedEx ABLE tools (Six Sigma). Create and maintain audit schedules for internal as well as registrar audits. Perform other duties as assigned. The Lead Auditor will lead and facilitate audits and audit teams at multiple facilities in support of facility certifications, new business implementation and quality risk based audits.

Bachelor's Degree or equivalent in a related quantitative field preferred and 4 years of relevant experience. In lieu of degree, high school diploma or GED and 8 years of relevant experience. At least 3 years of Quality Management Systems experience in Good Manufacturing Process (GMP) or similarly regulated facility.

Three years ISO experience in ISO9001 and ISO13485-medical required. Experience in one or more of ISO14001 - Environmental Management Systems, ISO45001, TL9000, 27001:2013 (IT) and/or R2 audit experience is also desired. Excellent verbal and written communication skills.

Customer service driven and strong team player. Ability to create and convey data, observations, finding, and recommendations using MS Office suite (Excel, Powerpoint, Word, etc.) or other software (Adobe, Captivate) to multiple levels of management. Travel required.

FedEx Logistics provides freight forwarding, as well as import and export services that allow companies to reach markets throughout the world. They help customers of all sizes solve the intricacies of shipping goods globally by providing comprehensive international ocean and air freight forwarding, surface transportation and distribution, customs brokerage, trade and customs advisory services, and advanced e-commerce and trade facilitation solutions. We're glad you stopped by and hope your job search experience with FedEx Logistics, Inc. will be rewarding.

We look forward to hearing from you! FedEx Logistics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their protected veteran or disability status.

FedEx Logistics, Inc. participates in the Department of Homeland Security U.S. Citizenship and Immigration Services' E-Verify program (For U.S. applicants and employees only). Please ready the E-Verify Notice available in English (https://e-verify.uscis.gov/emp/media/resourcesContents/E-Verify_Participation_Poster.pdf) and Spanish (https://e-verify.uscis.gov/emp/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf) before proceeding with your job application. Click here to read the Right to Work Notice available in English (http://ftn.fedex.com/careers/OSC_Right_to_Work_Poster.pdf) and Spanish (http://ftn.fedex.com/careers/OSC_Right_to_Work_Poster_ES.pdf). Additional information about the E-Verify program can also be found at www.uscis.gov.

Pay Transparency Policy Statement: The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless required to do so by law or the FedEx Logistics Legal Department.

Import Notice to All Applicants: FedEx Logistics is engaged in an industry regulated by federal law that prohibits it from employing convicted felons. Therefore, it must determine whether applicants have been convicted of felonies before a hiring decision is made.

A criminal background check will be required of all selected applicants before a hiring decision is made. Equal Employment Opportunity: As a federal government contractor, we are committed to employ and promote qualified minorities, females, individuals with disabilities, and covered veterans (including, but not limited to, disabled veterans, recently separated veterans, Armed Forces service medal veterans, and other protected veterans. Our philosophy and commitment to equal employment opportunity and non-discrimination is the bedrock to job opportunities for all employees and applicants without regard to an individual's protected status (i.e. race/ethnicity, color, national origin, ancestry, sex/gender, gender identity/expression, sexual orientation, marital/parental status, pregnancy/childbirth, or related condition, religion, creed, age, disability, genetic information, veteran status, or any other protected status.) Click here and here to read more about "Equal Employment Opportunity is the Law." FedEx Logistics will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the FAIR Chance Initiative for Hiring Ordinance (FCIHOO) for the City of Los Angeles (LAMC 189.00) FedEx Logistics will not rely on the wage history of a prospective employee from any current or former employer when determining the wages for such individual at any stage in the employment process, including in the negotiation or drafting of any employment contract in accordance with Philadelphia Ordinance No. 160840.



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Lead Auditor (Iso9001 And Iso13485 Medical Experience Required)

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VIEW JOBS 7/28/2021 12:00:00 AM 2021-10-26T00:00 Company: FedEx Logistics Job Title: Lead Auditor (ISO9001 and ISO13485 medical experience required) Job Requisition Number: RC362697 Time Type: Full Time Job Type: Regular Primary Job Posting Location: 145 Lt George W. Lee Memphis, Tennessee 38103 United States Posting Date: 2021-07-27 Job Posting End Date: 2021-07-30 The Lead Auditor will lead and facilitate audits and audit teams at multiple facilities in support of facility certifications, new business implementation and quality risk based audits. Perform internal audits, by leading an audit team or as a solo auditor, at multiple facilities (travel in the 40-50% range). Support new startup businesses by performing pre and post start up reviews. Monitor changes within International Organization for Standardization (ISO) and other quality standards to ensure current methods, practices and procedures are kept current. Communicate and coordinate with registrars and facilities to schedule audits and resolve findings. Generate formal audit reports and supporting evidence of results. Effectively communicate audit results to all levels of management. Ensure quality audit metrics are adequately captured, analyzed and communicated. Use the results of Audit to identify opportunities for improvement for all Quality Management System (QMS) processes. Manage and monitor nonconformities with respect to the QMS Procedure. Provide guidance and assistance on creation and implementation of Corrective and Preventive Action (CAPA's). Monitor the effectiveness of the Corrective/Preventive action process and conformance to the QMS Procedures driving timely and effective completion. Coordinate with regulatory department on facility requirements. Provide Quality project support using FedEx ABLE tools (Six Sigma). Create and maintain audit schedules for internal as well as registrar audits. Perform other duties as assigned. The Lead Auditor will lead and facilitate audits and audit teams at multiple facilities in support of facility certifications, new business implementation and quality risk based audits. Bachelor's Degree or equivalent in a related quantitative field preferred and 4 years of relevant experience. In lieu of degree, high school diploma or GED and 8 years of relevant experience. At least 3 years of Quality Management Systems experience in Good Manufacturing Process (GMP) or similarly regulated facility. Three years ISO experience in ISO9001 and ISO13485-medical required. Experience in one or more of ISO14001 - Environmental Management Systems, ISO45001, TL9000, 27001:2013 (IT) and/or R2 audit experience is also desired. Excellent verbal and written communication skills. Customer service driven and strong team player. Ability to create and convey data, observations, finding, and recommendations using MS Office suite (Excel, Powerpoint, Word, etc.) or other software (Adobe, Captivate) to multiple levels of management. Travel required. FedEx Logistics provides freight forwarding, as well as import and export services that allow companies to reach markets throughout the world. They help customers of all sizes solve the intricacies of shipping goods globally by providing comprehensive international ocean and air freight forwarding, surface transportation and distribution, customs brokerage, trade and customs advisory services, and advanced e-commerce and trade facilitation solutions. We're glad you stopped by and hope your job search experience with FedEx Logistics, Inc. will be rewarding. We look forward to hearing from you! FedEx Logistics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their protected veteran or disability status. FedEx Logistics, Inc. participates in the Department of Homeland Security U.S. Citizenship and Immigration Services' E-Verify program (For U.S. applicants and employees only). Please ready the E-Verify Notice available in English (https://e-verify.uscis.gov/emp/media/resourcesContents/E-Verify_Participation_Poster.pdf) and Spanish (https://e-verify.uscis.gov/emp/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf) before proceeding with your job application. Click here to read the Right to Work Notice available in English (http://ftn.fedex.com/careers/OSC_Right_to_Work_Poster.pdf) and Spanish (http://ftn.fedex.com/careers/OSC_Right_to_Work_Poster_ES.pdf). Additional information about the E-Verify program can also be found at www.uscis.gov. Pay Transparency Policy Statement: The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless required to do so by law or the FedEx Logistics Legal Department. Import Notice to All Applicants: FedEx Logistics is engaged in an industry regulated by federal law that prohibits it from employing convicted felons. Therefore, it must determine whether applicants have been convicted of felonies before a hiring decision is made. A criminal background check will be required of all selected applicants before a hiring decision is made. Equal Employment Opportunity: As a federal government contractor, we are committed to employ and promote qualified minorities, females, individuals with disabilities, and covered veterans (including, but not limited to, disabled veterans, recently separated veterans, Armed Forces service medal veterans, and other protected veterans. Our philosophy and commitment to equal employment opportunity and non-discrimination is the bedrock to job opportunities for all employees and applicants without regard to an individual's protected status (i.e. race/ethnicity, color, national origin, ancestry, sex/gender, gender identity/expression, sexual orientation, marital/parental status, pregnancy/childbirth, or related condition, religion, creed, age, disability, genetic information, veteran status, or any other protected status.) Click here and here to read more about "Equal Employment Opportunity is the Law." FedEx Logistics will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the FAIR Chance Initiative for Hiring Ordinance (FCIHOO) for the City of Los Angeles (LAMC 189.00) FedEx Logistics will not rely on the wage history of a prospective employee from any current or former employer when determining the wages for such individual at any stage in the employment process, including in the negotiation or drafting of any employment contract in accordance with Philadelphia Ordinance No. 160840. Fedex Cross Border Memphis TN

Lead Auditor (Iso9001 And Iso13485 Medical Experience Required)

Fedex