QA Engineer - IOL Division

Job Description

Role & responsibilities Job Purpose The purpose of the job for a Manufacturing QA Engineer is to ensure that the lenses (IOLs) are produced to meet the highest quality standards while adhering to all relevant regulatory requirements. The goal is to deliver safe, effective, and high-quality intraocular lenses at an optimal quality cost. Quality Ensure manufacturing process complies with standards in hydrophilic line. Establish quality assurance procedures and specifications. Ensure quality assurance procedures and specifications are followed. Maintain and update quality assurance records. Identify causes for defects and take necessary actions to eliminate or reduce the rejections. Establish and maintain Job Instructions for Quality Assurance. Identify and implement new tests and test methods to ensure the Quality of the product. Establish 4MTE condition for First time right product and ensure its implementation and sustenance in hydrophilic line. Perform data analysis and continual improvement in hydrophilic line. Internal quality audit and External audit Ensure availability of documents at the time of audit. Co-ordinate with QA Manager and Division regulatory team and fulfill the audit requirements. Ensure timely closure of audit findings. New product development Co-ordinate with R&D team in validation of proposed design and highlight deviations observed. Identify tests and test methods in support with R&D team to ensure quality of the product. Maintenance Co-ordinate with maintenance team and ensure preventive and corrective maintenance activities that affect product Quality are carried out as per plan. Training Train QA staffs and maintenance technicians on SOPs, JI and changes made to products or process in hydrophilic line. Internal Interaction Production team, R&D team, Regulatory team, Purchase team, Shipping team, Maintenance team, CNC team, Marketing team etc., External Interactions Suppliers or vendors, Surgeons, Dealers, External service providers etc., Preferred candidate profile Educational Qualifications Bachelors degree in Mechanical engineering Knowledge in statistics is an added advantage. Technical / Functional Skills Ability to solve problems effectively and efficiently. Hands on experience in MS office tools such as word, power point and excel. Hands on experience in using CAD software. Strong verbal and written communication skills.