Supplier Quality Engineer

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 114,000 colleagues serve people in more than 160 countries.

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 of which you dream.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• 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.

This position works out of our Sylmar, CA location. This is an onsite role.

As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

• Ensures that the Division 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 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.
• 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.
• 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.
• Assists with the evaluation and approval of supplier requested changes or improvements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Experience:

• Bachelor's Degree in Engineering or Technical Field or equivalent experience or an equivalent combination of education and work experience
• 2 years work-related experience
• Quality Assurance experience in the medical device or pharmaceutical, or other quality managed industries.
• Working knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 Solid communication and interpersonal skills.

• Masters Degree Preferred
• ASQ CQE or other certifications preferred.

Please note that the salary range listed is our full grade range. We usually hire based on the mid-point.

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Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

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.

The base pay for this position is $72,100.00 – $. In specific locations, the pay range may vary from the range posted.