Abbott Laboratories
Senior Supplier Quality Auditor
Abbott Laboratories, Chicago, Illinois, United States, 60290
ABOUT ABBOTT DIAGNOSTICSThe key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation, and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices, and clinics.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees via the Health Investment Plan (HIP) PPO.An excellent retirement savings plan with high employer contribution.Tuition reimbursement, the
Freedom 2 Save
student debt program, and
FreeU
education benefit - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.The OpportunityOur Diagnostics business currently has an opportunity for the role of
Senior Supplier Quality Auditor
for our
Chicago, IL , or
Santa Clara, CA
location. The primary function of this position is to administrate regulatory compliance activities related to the Internal Audit Program. The position is key in the facilitation/execution of the internal inspection process and ensures the Internal Audit Program across the Abbott Diagnostic business Sites/Commercial Affiliate Sites serves to identify Quality System improvements. Independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM's) to assess compliance with all applicable external standards and regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits.What You’ll Work OnPlans and conducts internal audits across the Abbott Diagnostic business Sites/Commercial Affiliate Sites to assess compliance with all applicable External Standards and Regulations as well as Abbott Quality System requirements.Identifies compliance risks to current regulations and guides the sites in the planning and execution of Quality System improvements.Prepares and implements Internal Audit schedules spanning the Abbott Diagnostic business manufacturing sites, Commercial Affiliate sites, as well as the scheduling and performance of Supplier / TPM audits.Uses current regulatory trends to identify potential compliance risks or opportunities for improvement in the Abbott Diagnostic business Quality System.Conducts internal audits at a standard commensurate with regulatory external audits.Leads initiatives to address compliance gaps across the Commercial Affiliate Sites, including the development of CAPA plans and resulting follow-up guidance activities in support of the Commercial Affiliates to attain the required level of compliance.Reports progress of audits within Sites and to Division personnel as appropriate.Provides guidance to applicable “Inspection-Readiness” activities across the Abbott Diagnostic business Sites.Performs topic-specific SIM audits at the Abbott Diagnostic business sites as requested by management.Reports audit findings in a timely manner.Generates and reports internal audit metrics to Site and Division Management.Maintains files and documentation associated with internal and external inspections.Participates as SME in audits; provides compliant and strategic solutions to complex quality issues.Leads cross-functional projects; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions. Maintains and demonstrates an understanding of global standards, regulations, and regulatory bodies. May assume managerial responsibilities as needed.The above statements are intended to describe the general nature and level of work that is being performed. Other duties may be performed as assigned.May mentor less senior level members of the group.EDUCATION AND EXPERIENCE YOU’LL BRINGMinimum QualificationsBachelors Degree preferably in Science or technical discipline such as Biology, Chemistry, Engineering or Certification in Medical Technology or Quality Management.Minimum 8 years of related experience in the medical device / pharmaceutical industry.Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820, 21 CFR Part 600, ISO 13485, and IVDD, etc.Trained in auditing techniques; Certified Auditor qualification or equivalent.Learn more about our benefits that add real value to your life to help you live fully:
http://www.abbottbenefits.com/pages/candidate.aspx . Follow your career aspirations to Abbott for diverse opportunities with a company that provides growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott , and Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.
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Freedom 2 Save
student debt program, and
FreeU
education benefit - an affordable and convenient path to getting a bachelor’s degree.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.The OpportunityOur Diagnostics business currently has an opportunity for the role of
Senior Supplier Quality Auditor
for our
Chicago, IL , or
Santa Clara, CA
location. The primary function of this position is to administrate regulatory compliance activities related to the Internal Audit Program. The position is key in the facilitation/execution of the internal inspection process and ensures the Internal Audit Program across the Abbott Diagnostic business Sites/Commercial Affiliate Sites serves to identify Quality System improvements. Independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM's) to assess compliance with all applicable external standards and regulations as well as Abbott Quality System requirements at a standard commensurate with regulatory external audits.What You’ll Work OnPlans and conducts internal audits across the Abbott Diagnostic business Sites/Commercial Affiliate Sites to assess compliance with all applicable External Standards and Regulations as well as Abbott Quality System requirements.Identifies compliance risks to current regulations and guides the sites in the planning and execution of Quality System improvements.Prepares and implements Internal Audit schedules spanning the Abbott Diagnostic business manufacturing sites, Commercial Affiliate sites, as well as the scheduling and performance of Supplier / TPM audits.Uses current regulatory trends to identify potential compliance risks or opportunities for improvement in the Abbott Diagnostic business Quality System.Conducts internal audits at a standard commensurate with regulatory external audits.Leads initiatives to address compliance gaps across the Commercial Affiliate Sites, including the development of CAPA plans and resulting follow-up guidance activities in support of the Commercial Affiliates to attain the required level of compliance.Reports progress of audits within Sites and to Division personnel as appropriate.Provides guidance to applicable “Inspection-Readiness” activities across the Abbott Diagnostic business Sites.Performs topic-specific SIM audits at the Abbott Diagnostic business sites as requested by management.Reports audit findings in a timely manner.Generates and reports internal audit metrics to Site and Division Management.Maintains files and documentation associated with internal and external inspections.Participates as SME in audits; provides compliant and strategic solutions to complex quality issues.Leads cross-functional projects; directly influences project direction and scope; champions new initiatives and acts as the catalyst for change within and potentially across Divisions. Maintains and demonstrates an understanding of global standards, regulations, and regulatory bodies. May assume managerial responsibilities as needed.The above statements are intended to describe the general nature and level of work that is being performed. Other duties may be performed as assigned.May mentor less senior level members of the group.EDUCATION AND EXPERIENCE YOU’LL BRINGMinimum QualificationsBachelors Degree preferably in Science or technical discipline such as Biology, Chemistry, Engineering or Certification in Medical Technology or Quality Management.Minimum 8 years of related experience in the medical device / pharmaceutical industry.Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820, 21 CFR Part 600, ISO 13485, and IVDD, etc.Trained in auditing techniques; Certified Auditor qualification or equivalent.Learn more about our benefits that add real value to your life to help you live fully:
http://www.abbottbenefits.com/pages/candidate.aspx . Follow your career aspirations to Abbott for diverse opportunities with a company that provides growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at
www.abbott.com , on Facebook at
www.facebook.com/Abbott , and Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.
#J-18808-Ljbffr