Available Position for Sr Quality Assurance Manager within the Medical Device. Full Time.
* B.S. in Science, Engineering, Engineering management, or related discipline.
* Master degree in Engineering or related discipline is a plus.
* Formal training in FDA regulatory quality system regulations (21 CFR 820) and applicable International Standards (ISO 13845) or equivalent education.
* Formal education or training on Quality Management tools and/or Continuous improvement methodologies, including TQM, Six Sigma, Lean Manufacturing, etc.
* Professional Certification is highly desirable (American Society of Quality, Association for the Advancement of Medical Instrumentation, etc).
* 10+ years of overall experience in a regulated industry – Medical Devices, Pharmaceutical or equivalent.
* 6 to 8 years of experience in Quality and Regulatory Compliance function or equivalent experience.
* At least 4 years of experience in Management position in Quality Assurance or equivalent position.
* Fully bilingual (Spanish, English)
* Excellent reading and writing skills
* Excellent oral communication skills
* Excellent analytical skills (Problem Solving, Critical thinking)
* Excellent interpersonal skills (relationships, influence, negotiation, teamwork)
* Demonstrated effective managerial skills
* Excellent organizational skills
* Computer literacy