Supplier QA Engineer II Job
Job Description Job Attributes+
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Job ID
31091634
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Req #
ABLAUS31091634ENUSEXTERNAL
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Job Location
Alameda, CA, US
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Job Category
Quality
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Job Type
Full time
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Travel
No
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Schedule
40 hours per week
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Alameda, CA location in the Diabetes Care division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
The Supplier QA Engineer II supports in the evaluation, 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.
What You’ll Work On
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 statuses, 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.
Required Qualifications
Bachelor’s degree or an equivalent combination of education and work experience
Minimum 6 years of Quality Assurance experience in the medical device, pharmaceutical or other quality managed industries
Preferred Qualifications
Some working knowledge of applicable regulations such as FDA, QSR, ISO, MDD, or IVDD
Some knowledge in the areas of design controls, verification and validation activities, manufacturing practices and statistical techniques.
Some experience in conducting external quality assessments.
Certified Lead Auditor trained
Proficient in MS Office (Word, Excel, Outlook)
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.
Job Skills
- quality assurance
- qsr
- supplier quality management
- quality control
- supplier evaluation
- engineering expertise
- supplier assessment
- quality control management
- document control
- supplier quality assessment
- supplier approval
- supplier site visits
- supplier performance monitoring
- project management
- supplier communication
- supplier status notification
- inspection approval
- statistical techniques
- supplier performance
- exception report evaluation
- supplier improvement recommendation
- supplier list management
- data preparation
Additional Information
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.