27 Job openings found

Description : Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking). Ensure that products meet all regulatory requirements and maintain relevant documentation. Quality Assurance: Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. Collaborate with production teams to establish quality control ...

DUTIES AND RESPONSIBILITIES: To coordinate import export activities. To planning and managing logistics, warehouse, transportation and customerservices. To directing, optimizing and coordinating full order cycle. To keep track of quality, quantity, stock levels, delivery times, transport costs andefficiency. To negotiate rates and contracts with transportation and logistics providers. To recommend ...

Assist in ensuring product quality and compliance with regulatory standards, including MDR and QMS requirements. Support the preparation and maintenance of quality manuals, formats, and SOPs under guidance. Conduct routine document reviews, including COAs, calibration reports, and sterilization checklists. Participate in internal audits and assist with audit documentation and follow-ups. Maintain and update records ...

Former experience in the following: Working in Medical Device: Initiate, monitor, and verify the effective implementation of the Quality Management System in all areas of company activities Regulatory submissions: Regulations requirements of the ISO 13485; FDA; CE (MDD/MDR) and MEDDEV Composing and maintaining quality manual procedures (i.e., SOP’s), Follow the requirements of GLP/GMP. Internal ...

Job Description:1. Responsible for Overall QA activities & to look after QMS compliance in accordance with ISO 13485/cGMP.2. Preparation & Up-gradation of SOP, Specifications3. Maintain the Records of BMR, BPR, Batch Inspection Documents4. Maintaining Document & Record Control5. Preparation & Up-gradation of Routine Validation Protocol & Reports.6. Handling CAPA, Non- ...

Job Description: Knowledge of Medical device industry standard like ISO 13485: 2016, CE, CDSCO etc. would be an advantage.Responsible to prepare production planning, review as per requirements defined by Sales team Responsible to communicate with Quality, sales, purchase & marketing team as per the requirement.Shall proficient in verbal & writing communication ...

Quality Assurance Specialist Responsibilities: Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS). Conduct internal quality audits and participate in management review meetings. Handle investigations of complaints and implement corrective and preventive actions. Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in ...

A Day in the Life   One of the key deliverables of MIDC is an electromechanical product that will be used in a clinical setting.  We are looking for a Lead systems engineer who will work on capturing system requirements, concept design, system modelling, risk analaysis, system.  Given the entrepreneurial nature of ...

Job Overview: The Manager – Global Statutory Compliance will be responsible for ensuring the company's dental implants and medical devices adhere to international regulatory standards, including ISO 13085, FDA, and other country-specific statutory requirements. This role will involve overseeing the creation and management of Design History Files (DHF), ensuring proper document ...

The job description is as below: 1. Well acquainted with latest ISO 13485:2016 , CE & CDSCO norms forMedical Devices all class ( Preferably cardiac)2. Having experience of preparing dossiers for varieties of countries andtheir rules and regulations.3. Must have experience of handling ISO , CE & CDSCO audits.4. Experience of ...