The Opportunity Provides support in the evaluation of materials, components, product, and work process within the quality system.
Participate on technical assistance to support efforts ensuring the quality of the product.
Assists validations, testing and troubleshooting process to improve processes, products and new product introduction.
Assists developing methods and procedures to control or improve the processes.In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.What You'll Do• Assist in the review of material, equipment and systems quality through examination, inspection, measurement or testing of raw materials, components, subassemblies, packaging, labeling and documentation.• Audits and verifies processes such a line verification to prevent quality system and manufacturing impact.• Reviews and verifies compliance of quality and manufacturing documentation such batch records, reports of nonconforming material and inspection records.• Assists engineering in providing manufacturing support by reviewing and analyzing data to determine manufacturing issues or trends.• Assist on quality testing of samples as part of its daily activities with no or little guidance from the Quality Engineer.• Coordinates with Quality Engineer to Identify and segregates nonconforming material from the production line and handle the material in and out of the designated quarantine area according to governing documents.• Assist in writing, executing and documenting qualifications and validations of equipment, product, process, and test method verifications, with mentorship from Quality Engineer.• Collect data, summarize, analyze, and perform statistical analysis for manufacturing, development processes, process validation and/or quality systems requirements.• Provides support in the process related to nonconformance actions (corrective, preventive or corrections) or process improvement projects and executing all required activities to implement it as: generated document redlines, write and submit Change Order requests, form and inform the group involved in the change, etc.• Assists to sets up and in the training for the new or transferred Quality Technicians• Provides support for the proper completion of the Internal Customer Signal (ICS): units' delivery and examination, root cause analysis, document investigation, complete corrections or actions as required.• Provides or ensures internal customers received required quality documentation such Certificates of Conformance (CoC) and Certificates of Analysis (CoA)• Assist Engineering in activities related to create, assess and improve control plans, and process monitoring in manufacturing areas.• Assist the document investigations, root cause analysis of the manufacturing analysis process.• Assists in the writing of Build as Risk (BAR's) forms.• Prepares quality data for Functional Team, cross site meetings and monthly Quality Reports.
Assists Quality Engineering by presenting quality updates as required.Required QualificationsHigh School Degree Student of Engineering (At least 60% of degree completion) or Quality Technical Degree, engineering, quality or related fields or 5 years of equivalent experience as Quality Technician or areas related to Quality in medical devices or pharmaceutical quality control.3 years of experienceExperience as Quality Technician or position related to Quality Control.Knowledge or technical concepts and/or basic develops technologies or processes.
Understanding of product or systems fundamentals in cross functional areas.Experience on Interpret and utilize numerical and statistical data to present documentation, analysis and resolve problems.Knowledge of Quality Systems/engineering required.Demonstrated computer skills and basic MS Office knowledge.3 years of experience would be considered equivalent to 80% of credits completed in an engineering related career.Preferred QualificationsIntermediate Commands of English / RequiredStatistical knowledge including statistical software (Minitab, JMP)Previous experience in assisting with validations, qualifications, test methods or NCMR.Knowledge in blueprint reading and experience with sampling techniquesExcellent interpersonal and communication skillsCertified Quality Technician (CQT) or Certified Quality Engineer (CQE)Shift A: Monday - Friday 6:00am to 3:30pm.