Senior Supplier Quality Auditor

The Opportunity

Our 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 to 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 On

• Plans and conducts internal audits across the Abbott Diagnostic business Sites / Commercial Affiliate Sites to assess compliance to 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. This may include 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 projects that are cross-functional in scope; 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 BRING

Minimum Qualifications

• Bachelors 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.

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.