DESCRIPTION

Provide technical analysis of processes that are involved in the development of products and the manufacturing of products in order to ensure that products developed and manufactured are consistent and meets specifications. Help and support such activities why ensuring that applicable standards and procedures are followed. Mentor and train junior level Quality Engineers.

Participate in Project teams and representing Quality/Regulatory groups and ensuring that Design Control requirements are met. Support Corrective and Preventive actions and ensure that Root Cause Investigations are performed using appropriate Quality Tools. Support Manufacturing processes and ensure that validation activities are well documented and performed.

RESPONSIBILITIES

·        Ensure that appropriate procedures are established to support Design Development and the Manufacturing processes.

·        Review of design and development processes and ensuring that appropriate documentations are established during this process and in accordance with the Design Control procedures.

·        Review manufacturing and validation activities to ensure that they are well established and compliant with the regulations.

·        Establish purchasing controls and work very closely with suppliers of critical components and sub systems.

·        Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis.

·        Provide leadership in the application of Quality Tools such as Risk Management, Root Cause Investigations, Designs of Experiments, Capability Studies, in the establishment and investigation of process and products failures and implement lasting solutions of such failures.

·        Develop process flow diagrams and perform gap analyses on current controls versus required controls.

·        Establish methods to analyze and investigate the root cause of external and internal non-conforming products.

·        Assist in corrective and preventive actions and verifications of effectiveness checks.

·        Analyze data from customer complaints, internal audits, and internal and external suppliers non-conformance and implement appropriate solutions.

·        Develop inspection procedures and apply statistical technics and appropriate sample plans.

·        Gather, analyze, and report data reflecting status of product and process and provide recommendations to improve such activities.

·        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.

·        Participate in Audits (Internal and External), and Regulatory authority inspections and ensure that risk to company is minimized as much as possible.

REQUIREMENTS

·        Strong Validation/Design Control experience is highly preferred. Experience in molecular is highly preferred.

·        Bachelor’s Degree preferred in an Engineering discipline such as Mechanical, Electrical Industrial or Manufacturing Engineering.

·        Three to Five years related experience in IVD, medical, pharmaceutical, or other related industry.

·        Must have a thorough understanding of statistical analysis, statistical process control, Investigation and Root Cause Analysis, Corrective and Preventive Action Process, and their application to development and manufacturing processes as a problem identification and resolution tool.

·        Proficient in Quality Analysis Tools (Taguchi, Fishbone) & DOE.

·        FDA Product and Process Validation Techniques.

·        Solid experience in Systems Development including Hardware (Instrumentation), Software and Consumable/Reagents as applicable in IVD Industries.