3.0 - 7.0 years

0 Lacs

pune, maharashtra

On-site

As an experienced professional with 3-4 years of overall experience, you will be responsible for a variety of tasks in the manufacturing industry in Pune. Your role will involve the following key responsibilities: - Good in documentation, particularly in regulated industries like Medical device, Pharma, and Aerospace. Your experience in authoring documents and working with GDP will be highly beneficial. - Proficiency in statistics to support various activities within the manufacturing process. - Effective communication skills to facilitate discussions, especially in handling manufacturing activities. - Hands-on mentality to perform activities related to PV, such as TMV, IQ, OQ, and PQ. Experience on the shop floor would be advantageous. - Conducting gap assessments and remediation of documents with stakeholder inputs. - Understanding manufacturing-specific QMS documents for Class I, II, and III medical devices. - Supporting the development and introduction of new products, processes, and technologies with a focus on quality systems. - Managing development, regulatory compliance, and process risk management including pFMEA. - Creating and modifying process flows within Manufacturing/Service Departments. - Developing and maintaining Manufacturing/Service Work Instructions and related documents. - Creating and modifying fixtures, tooling, equipment, and systems to support operations. - Conducting IQ, OQ, and PQ of fixtures, tooling, and equipment. - Monitoring and driving corrective action, CAPA, and continuous improvement activities by conducting primary investigations, data analysis, and implementing corrective actions. - Supporting corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. - Preference will be given to candidates with Medical Device Experience and knowledge of FDA 510 K, IS013485, and ISO 14971 standards. Your educational background should include a BE/B.Tech/ME/M.Tech degree. Make sure to bring your hands-on experience and expertise in documentation, communication, and quality systems to contribute effectively to the manufacturing processes and operations.,

Posted 4 days ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.