Responsible for evaluating and optimizing manufacturing, QC, R&D and CAPA processes to improve product consistency and to increase productivity.
Responsible for reviewing, performing, and documenting validations for new and existing products.
Supports all applicable regulations including but not limited to FDA, ISO, and CMD/CAS requirements
Review of design, manufacturing, purchasing, and test documentation to ensure quality requirements are fulfilled.
Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis.
Provide leadership in and employ advanced quality planning techniques (FMEA, Capability Studies, Measuring and Test Equipment Studies, Product Validation and Reliability Test)
Determine process/equipment capabilities.
Develop and control implementation of SPC techniques
Develop process flow diagrams and perform gap analyses on current controls versus required controls.
Analyze and investigate the root cause of external and internal non-conforming products.
Assist in corrective and preventive actions and verifications of effectiveness such as actions for customer complaints, internal audits, and internal and external suppliers non-conformance.
Perform assessments for process-related risks.
Develop inspection procedures and justified sample plans.
Gather, analyze, and report data reflecting status of product and process and provide recommendation to improve.
Design and conduct experiments that test current process controls to prove efficacy and recommend new controls if current controls are deficient.
Support new product development and growth. Represent quality on new product development teams.
Participate in improvement and lean projects.
Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
Perform other duties as assigned.
EDUCATION and/or EXPERIENCE
Bachelor s degree preferred in an engineering discipline such as Mechanical, Electrical or Industrial Engineering.
Three five years related experience in IVD, medical, pharmaceutical, or other related industry.
Must have a thorough understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool.