Supplier Quality Engineer III

at  Abbott Laboratories

REQUIRED QUALIFICATIONS

• Bachelor’s Degree in STEM careers (engineering, Science or equivalent).
• 3+ years oexperience, with 2+ years in Quality Engineering roles. Preferrable in supplier quality engineering roles
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• Prior medical device experience.
• Demonstrated use of Quality tools/methodologies, such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
• Knowledge of FDA, GMP, QSR CFR 21 Part 820 and ISO 13485.
• Experience implementing various product and process improvement methodologies.
• Technical writing Experience.
• Quality Auditor experience for ISO 13485 or 9001.
• Ability to travel approximately 10-40%, including internationally.
• Intermediate statistics knowledge
• Language Proficiency
• Advance Commands of English / Required

PREFERRED QUALIFICATIONS

• Demonstrated supervisory experience.
• ASQ CQE, CQA or CSQP certification preferred.
• Quality Auditor training for ISO 13485 or 9001.
• Previous Supplier Quality engineering or Receiving Inspection experience.
• Experience with SAP supply chain modules or similar ERP system.

• Assesses potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier. Evaluates, monitor and approve new and existing external suppliers based in their qualifications and performance, acts as a spokesperson to external suppliers.
• Generates test protocols, monitors testing, issues material qualification test reports and approves components for use.
• Assists in generating component specifications, generates and maintains incoming inspection procedures and provides input from component quality, inspectability and manufacturability perspective. Trains inspectors to these procedures as require
• Leads in maintenance and improvement Abbott supplier quality program policies, procedures and forms.
• Provides engineering guidance to Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.
• Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.
• Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.
• 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.