Quality Applications Specialist - Juncos

Descripción del Empleo:
**New Openings** Designs inspection and testing mechanisms and equipment; conducts quality assurance tests; performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Reviews and analyzes quality trends with the manufacturing team. Provides leadership to in-depth investigations and cross-functional, multilevel technical teams to assure causes of non-conformance are identified and understood, and that corrective/ preventive actions are implemented. Evaluates implemented corrective and preventive actions against trends and quality issues to assess effectiveness.
Leads investigation of customer complaints in alignment with the manufacturing engineers, and process supervisors, facilitates the implementation process.
Temporary Contract. 22544-3 21938-2 22022-4 22544-3 22978-3
Requisitos:
Bachelors Degree in Science (Chemistry or Microbiology) or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical. PE License is a plus. At least 3-5 years experience in quality engineering in manufacturing environment (pharma, medical device). Experience executing some or various of the following Validation/Qualification activities in medical device or pharmaceutical manufacturing: Software Validation, Computer Systems Validation (CSV), Raw Materials/Suppliers Qualifications, Cleaning Validation, Manufacturing/Packaging Equipment Validation, Lab Equipment Validation, Process Validation, Product Transfer, Method Transfer & Validation, Automation, Change control documentation. Proficient knowledge in statistical analysis of data, evaluation, investigation and document non-conformance, use of MiniTab.