QMS Engineer

Job Description

Quality Engineer- QMS – Medical Device development Phillips-Medisize, a Molex company, is looking for an experienced Quality engineer for Global Innovation Development in Bangalore, India. If you are interested in being part of a project organization and passionate about creating unique products for people who need medical treatment it might be you, we are looking for. The Quality Engineer will focus on handling QMS activities in the site and will ensure that QMS (Quality management system) operates efficiently and complies with quality manual and ISO13485:2016 standard requirements. The Medical Device Quality Engineer will also support sustaining engineering activities and provide support to the Quality organization for quality initiatives. Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. What You Will Do In Your Role For our new Quality engineer the field of work will be Quality Assurance in Medical Device development division and you will do below activities- Handling of QMS activities like, change management, QNs, Deviations, CAPA in a cooperation with colleagues. Handling Quality Notifications/deviations, Audit findings and performing investigation with tools and ensuring timely closure of QNs. Handling CAPAs, identifying corrective action and preventive action and ensuring timely closure of CAPAs. Handling of QMS changes through change management process and ensure that changes are implemented to site with proper impact assessment and risk controls and to ensure timely closure of relevant actions. Training management of the site personnel for new hire and on-going training and to ensure timely completion of trainings. Providing necessary QMS related training to the site people as and when needed. Support in audit for QMS related activities. Tracking and monitoring of site KPIs as per defined frequency. Support manufacturing, in-process quality control, incoming and outgoing quality control to work according to our Quality Management System. Implement customer requirements into our processes. Identify and implement improvements of the processes, including the way we operate our ERP system (SAP). Handle and implement any new QMS tools to the site as and when needed. Handle deviations and CAPAs in cooperation with colleagues. Communicate with our global site for any QMS related topics. Handling document management, issuance and archival activity. The Experience You Will Bring Requirements: Minimum Bachelor’s degree/Diploma in engineering. Minimum 4+years of experience working as a Quality Engineer for medical device industry and any other regulated environment. High understanding of the importance of maintaining a high level of quality and documentation. Result oriented and a self-motivated team player. Pro-active in identifying and implementing potential improvement and proposing Lean solutions. Fluent in English, both spoken and written. Proficiency with MS Office, MS Excel, MS Power Point What Will Put You Ahead: Knowledge of ISO 13485, 21 CFR part 820 Knowledge of investigation tools Experience working with quality management and/or good documentation practices for medical devices. We offer you A great work culture which is highly human centric driven under the guidance of Principle based management which foster everyone to learn & grow to achieve career aspirations. A challenging position in an international innovative and successful company that is growing. An opportunity to setup the processes and development team in India to support the Indian customers. An opportunity to become part of a global team of dedicated and highly qualified colleagues based in Bangalore, India. Well-structured training and continuous development of your competencies. Exciting career possibilities within the constantly growing area of medical devices. Salary on a competitive level. The Company – In Short Phillips Medisize is an expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Phillips Medisize is a part of Molex. We have opened a new Global Innovation and Development center in Bangalore, India and expected to grow in the Asian region. Show more Show less