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4 months ago
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Senior Supplier QA Auditor


Abbott
Location: UK
Job type: Permanent
Category: Operations Jobs
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Germany - Wiesbaden-Delkenheim







Germany - Berlin







Italy - Rome







Germany - Köln







Netherlands > Hoofddorp : Wegalaan 9







Italy - Remote







Italy - Milan







Poland - Remote







Netherlands : Remote







Ireland - Dublin







Germany -Hamburg







Spain - Madrid







Belgium - Diegem







Netherlands - Weesp







United Kingdom - Remote







Germany -München







Germany -Aachen







Czech Republic - Prague





JOB DESCRIPTION:

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

In Germany, Abbott has more than 3,000 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn and Witten. Alere in Cologne and Jena is now Abbott.

Abbott Diagnostics Division (ADD) is looking for a

Manager Supplier QA Auditor (w/m/d) home-based

field based out of any European country in which Abbott has an affiliate such as e.g. Germany, Italy, UK, Czech Republic, The Netherlands, Spain.

Independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM) 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 Subject-Matter-Expert (SME).

Future career trajectory (3-5 years) possibilities would include roles such as Manager and/or Director of Internal Audit Program, Supply Chain Quality Assurance

Main Responsibilities:

Responsible for implementing 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

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
Fluent English and add. European Languages are a plus
Travel time 35-40% in Europe, Asia and Latin America

Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application.

JOB FAMILY:
Operations Quality

DIVISION:
ADD Diagnostics

LOCATION:
Germany > Wiesbaden-Delkenheim : G01

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 25 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Germany - Wiesbaden-Delkenheim







Germany - Berlin







Italy - Rome







Germany - Köln







Netherlands > Hoofddorp : Wegalaan 9







Italy - Remote







Italy - Milan







Poland - Remote







Netherlands : Remote







Ireland - Dublin







Germany -Hamburg







Spain - Madrid







Belgium - Diegem







Netherlands - Weesp







United Kingdom - Remote







Germany -München







Germany -Aachen







Czech Republic - Prague





JOB DESCRIPTION:

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

In Germany, Abbott has more than 3,000 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn and Witten. Alere in Cologne and Jena is now Abbott.

Abbott Diagnostics Division (ADD) is looking for a

Manager Supplier QA Auditor (w/m/d) home-based

field based out of any European country in which Abbott has an affiliate such as e.g. Germany, Italy, UK, Czech Republic, The Netherlands, Spain.

Independently conducts assigned audits of Suppliers and Third Party Manufacturers (TPM) 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 Subject-Matter-Expert (SME).

Future career trajectory (3-5 years) possibilities would include roles such as Manager and/or Director of Internal Audit Program, Supply Chain Quality Assurance

Main Responsibilities:

Responsible for implementing 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

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
Fluent English and add. European Languages are a plus
Travel time 35-40% in Europe, Asia and Latin America

Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application.

JOB FAMILY:
Operations Quality

DIVISION:
ADD Diagnostics

LOCATION:
Germany > Wiesbaden-Delkenheim : G01

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 25 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Not Applicable
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