Our company specializes in providing Integrated Engineering, Maintenance, Utilities and Specialized Technical Services for the Pharmaceutical, Parenteral, Chemical, & Medical Devices Manufacturing business sectors in compliance with Federal Government Regulations.
Qualifications and Skills
Bachelor Degree in Engineering or Life Science and three (3+) years of experience within Medical Device industry.
Exposure to engineering and manufacturing environment
Quality and Results Oriented
Fluency speaking and writing in English and Spanish
Root Cause Analysis
Technical Writing and Composition
Responsibilities and Duties
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and 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.
Considering the quality trends provides directions in terms of setting work priorities for process enhancement.
Provides leadership to effective in-depth investigations and to cross-functional, multilevel technical teams to assure causes of non-conformance are identified and understood, and that sound corrective/ preventive actions are implemented.
Evaluates the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of it.
Leads investigation of customer complaints in alignment with the manufacturing engineers, and process supervisors, facilitates the implementation process.
Analyzes data based on trends, recommends actions for process, equipment and system improvement.
Writes procedures, protocols and any other documentation needed for the enhancement of systems.
Provides training and education to the manufacturing team on tools for process, monitoring enhancement, procedures and equipment, analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISO requirements. Drives implementation of these tools.
Analyzes problems regarding inspection procedures, reaches decisions and recommends possible solutions and improvements to implement corrective and preventive actions.
Initiates, reports, and recommends special studies and qualification of new products or processes to evaluate quality and reliability.
Analyzes and submits recommendations for facilities, environmental areas, such as particulates, humidity, calibrations, and other monitoring.
Drives SPC or preventive action methods.
Reviews and approves qualification / validation reports, ECO's/CA's, process changes, quality records or manufacturing documentation.
Implements quality system improvements.
Conducts and assists in regulatory inspections, such as (TÜV, FDA, others), as well as internal audits.
Integrates Quality Systems Regulations into New Product & Technology Development.
Performs other position duties as assigned.