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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.
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.

What You'll Do

• Applies subject matter knowledge in the area of Supplier Quality management.
• Responsible for conducting supplier audits, supplier evaluations & qualifications, supplier change notifications(SCN), supplier corrective action request (SCAR), and understand supplier management key performance indicators.
• Creates supplier audit plans and execute supplier audits to build supplier relationships and ensure compliance to Abbott's requirements.
• Evaluate suppliers utilizing a risk-based approach and collaborates with requestors to ensure business and compliance requirements are met to qualify suppliers.
• Drives all SCAR activities to closure.
• Familiar with SCAR 8D methodology and Root Cause Analysis methods such as: 5 Why's, Fishbone diagram, Fault Tree Analysis, Pareto Charts, Scatter Plot Diagram.
• Resolve Supplier Quality related-nonconformance activities that may include investigations, sort/rework instructions, and sending supplier communications.
• Collaborate with suppliers as needed to ensure their performance is acceptable per site Supplier Quality metrics.
• Works with Research and Development(R&D), manufacturing, procurement, and purchasing when evaluating and monitoring supplier performance.
• Understand Process Failure and Effects Analysis (PFMEA), Design Failure and Effects Analysis DFMEA, Health hazard risk evaluation, and other risk management tools.
• Leads supplier process validations, supplier test method validations, supplier Gage Repeatability and Reproducibility (GR&R), first article inspections, and supplier attribute agreement analysis, with suppliers when required to ensure consistent Supplier Quality.
• Review and approve drawings, receiving & inspection plans, and specifications based on Abbott's requirements.
• Change agent for SCNs and works with all stakeholders to execute all deliverables required for SCNs.
• Working knowledge of regulations and standards affecting in vitro diagnostic's devices such as: ISO 13485, ISO 14971, ISO 17025, ISO 9001, FDA 21 CFR 820, 98/79/EEC (IVDD), 2017 /746 EU (IVDR).

Minimum Qualifications

• Bachelor's degree in science, technology, engineering, or mathematics
• Minimum 1-year related experience in research and development, Supplier Quality, or quality related positions in a regulated industry
• Proficient with Microsoft Office Suite.
• Demonstrates excellent written and oral communication skills.
• Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner.

Preferred Qualifications

• ISO 13485 and lead auditor certifications or equivalent.
• General understanding of geometric dimensioning & tolerancing (GD&T) for specifications associated with supplier manufacturing process to be able to provide technical input
• Familiarity with using Minitab or other statistical analysis software.

The base pay for this position is
$65,200.00 - $130,400.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
CMI ARDx Cardiometabolic and Informatics
LOCATION:
United States > San Diego : 7220 Trade Street Sorrento Ridge
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 5 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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