27 Job openings found

Quality Engineer Standards and Regulations Good knowledge of the relevant Standards/Regulations for medical device manufacturers (ISO 13485, ISO 14971 , MDD, MDR, 510(k) etc.) Ensuring compliance of products as per MI PLM and SHPL QMS requirements Co-ordination with Quality Assurance Manager on various SHPL QMS related activities Conducting/participating in Internal Audits and ...

Quality Engineer Standards and Regulations Good knowledge of the relevant Standards/Regulations for medical device manufacturers (ISO 13485, ISO 14971, MDD, MDR, 510(k) etc.) Ensuring compliance of products as per MI PLM and SHPL QMS requirements Co-ordination with Quality Assurance Manager on various SHPL QMS related activities Conducting/participating in Internal Audits and External ...

Job Profile for QA/RA :  1-2 Years of Experience ? Experience to prepare and review the documentation required for the ISO 9001:2015,EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745,IMDR 2017.? Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s,Change Control, Deviation, CAPA, Incident, and Customer ...

Job Profile for QA/RA :  2 -3 Years of Experience ? Experience to prepare and review the documentation required for the ISO 9001:2015,EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745,IMDR 2017.? Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s,Change Control, Deviation, CAPA, Incident, and ...

Experience to prepare and review the documentation required for the ISO 9001:2015, EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745, IMDR 2017. Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s, Change Control, Deviation, CAPA, Incident, and Customer complaint, Management Review Meeting, pdate Harmonized Standards, ...

Position:         Manager - Engineering  Location:        Daman Experience:     7 to 15 Years Industries:      Pharma   Responsibilities: Lead, manage, and mentor a team of engineers to deliver high-quality medical devices, ensuring design, development, and manufacturing goals are met on time and within budget. Oversee the engineering design and product development processes, ...

JD For QARA                                                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 & Process Management Supervise day-to-day manufacturing of PTCA balloons as per defined SOPs. Monitor critical process parameters such as extrusion, balloon forming, pleating, folding, bonding, and assembly. Ensure production output meets planned schedules, quality standards, and yield targets. Identify and troubleshoot process deviations, implement corrective and preventive actions (CAPA). Quality & Compliance Ensure ...

Key Responsibilities- Monitor and ensure compliance with quality standards at every stage of production from raw material to finished goods- Implement and maintain documentation for QA processes, batch records, and product testing reports- Conduct in-process and final inspections of products like abdominal belts, LS belts, cervical collars, gauze swabs, etc- ...

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 ...