Quality Engineer (Electromechanical Medical Device)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

Key Responsibilities

• Responsible for Supplier Quality Management cycle.
• Primary contact with suppliers on all quality related issues during both supplier maintenance & supplier selection process.
• Oversee supplier quality management activities & continuous improvement initiatives with suppliers.
• Plan & lead required supplier audits.
• Establish & maintains supplier quality metrics, scorecards, & trending.
• Generate quality plans & define risk control measures for continuous improvement.
• Conduct Design of Experiments (DOE) & Process Characterization for process optimization &/or improvement by conducting analyses using statistical techniques, including Gage Repeatability & Reproducibility (Gage R&R), Tolerance intervals, & Process Capability assessments with Cp or Cpk Lead or support design activities including design verification, validation, specification setting & justification, test method development, usability engineering, & risk management.
• Plan & conduct product & process verification & validation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ).

Qualifications

Education & Experience

Must possess a Bachelor’s degree in engineering (mechanical, industrial, chemical, electrical), or

other technical discipline. Must have 1 year  of quality engineering work experience in FDA regulated medical device manufacturing environment(s).

If experience required, must have 1 year of related work experience:

1. conducting analyses using statistical techniques, including Gage R