• Abbott
  • $103,730.00 -157,700.00/year*
  • Pomona , CA
  • Engineering
  • Full-Time
  • 801 Alicia Ct


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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 the division'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 division s 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 division s 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 status as they relate to the Agile Manufacturer's Tab.
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. 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).
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. Drives improvement projects, as required, to improve supplier performance.
Assists in the preparation of area metric data for delivery to Sr. Management. Recommends areas for supplier improvement, as appropriate.
Participates with Incoming Quality Control on the development of incoming inspection activities or the reduction of these activities through implementation and maintenance of the Material Certification Program.
Responsible for approving First Article Inspections and/or Golden Samples, as initiated by suppliers.

Qualifications:

Bachelors Degree or an equivalent combination of education and work experience. Minimum 6 years Quality Assurance experience in the medical device, pharmaceutical or other quality managed industries. Working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD. Knowledge in the areas of design controls, verification and validation activities, manufacturing practices and statistical techniques. Experience in conducting external quality assessments. Certified Lead Auditor trained. Molding experience to include mold qualifications and process validation preferred. Supplier quality systems experience desired.


Associated topics: biochemistry, bioengineering, bioinformatic, biomedical engineer, biophysics, enzyme, medical, metabolic, msat, therapeutic

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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