Offers “Abbott”

Expires soon Abbott

Principal Quality Engineer

  • Internship
  • Austin (Travis)

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Supports in the selection, approval and maintenance of ADC’s approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities.

Responsibilities:

- Ensures that the ADC Approved Supplier List is maintained and accurate.

- Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of on-site or desk top audits, and review of other objective evidence, as required.

- Communicates ADC approval requirements to supplier and monitors feedback per project timelines. Performs on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings.

- Ensures Document Control is notified of any changes to supplier statuses, as they relate to the Agile Manufacturer’s Tab.

- Responsible for managing Third Part Manufacturers, which are suppliers that procure, assemble, test, accept and package products for distribution on ADC’s behalf.

- Ensures that the supplier performs and documents the appropriate engineering approach to activities such as qualification and validation and provides assistance in these efforts, as appropriate.

- Leads in the evaluation and approval of supplier requested changes or improvements.

- Supports in the selection, approval and maintenance of ADC’s approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement activities.

- Leads projects, as related to supplier quality and department initiatives, improvement projects, as required, to improve supplier performance.

- Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues.

- Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action.

- Monitors supplier performance and reports supplier quality trend data.

- Assists in the preparation of area metric data for delivery to Sr. Management.

- This activity may also include the identification and/or approval of a new supplier to provide an alternate material.

- Conducts site visits at supplier sites to bring back understanding on how to resolve quality issues (process audits).

- Maintains an active role with new product development teams to assist in supplier selection and approval and to provide support, as required.

Qualifications:

Bachelors’ Degree required (Science or Engineering disciplines preferred).  Minimum of  9 years Quality Assurance experience in the medical device or pharmaceutical or other quality managed industries.  Extensive knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD.  Certified Lead Auditor trained and experience in conducting external quality assessments.  Well developed written, oral and interpersonal skills.   Knowledge in the areas of Design Controls, Verification and Validation activities, manufacturing practices and statistical techniques.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

United States > Texas > Austin : 12501B Research Boulevard

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 20 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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