30 days old

Senior Supplier QA Auditor

Maidenhead, England SL6

Primary Job Function

Independently conducts assigned audits of Suppliers and TPMs 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. May participate in audits of manufacturing and commercial affiliate sites; involved in projects that are cross-functional/cross-divisional in scope as SME.

Core Job Responsibilities:

Responsible forimplementing and maintaining the effectiveness of the quality system.

Independently conducts and leads audits across ADD's Supplier and TPM network.

Identifies compliance risks to current standards / regulations and may guide in the planning and execution of Quality System improvements.

Ensures compliance to Division and Corporate policies and procedures by promptly reporting non-compliance issues.

Provides guidance and trains colleagues; provides oversight to one or more junior level auditors.

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 understanding of global standards; regulations and regulatory bodies.

May assume managerial responsibilities as needed.

Position Accountability / Scope

Reports to Manager; Global Compliance and Auditing.

Carries out assigned duties and tasks related to area of responsibility with management guidance; may be responsible for decision making.

Minimum Education

Apprenticeship or Bachelor's degree in Life Science; Engineering or closely related discipline is required. Experience in the medical device / pharmaceutical industry.

Minimum Experience / Training Required

Knowledge of Good Manufacturing Practices (GMPs), Quality System standards and regulatory requirements such as 21 CFR 820; ISO 13485; IVDD; etc.

Trained in auditing techniques; Certified Auditor qualification or equivalent is required.

Excellent written and verbal communication skills.
Job Family: Operations Quality
Division: ADD Diagnostics
Additional Location: Ireland - Donegal Town
Travel: Yes, 50 % of the Time
Medical Surveillance: Not Applicable
Significant Work Activities: Not Applicable


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Senior Supplier QA Auditor

Maidenhead, England SL6

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Maidenhead, England

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