31 Design Controls Jobs - Page 2

As a Design Quality Engineer at our company, you will play a crucial role in ensuring the quality assurance aspects of product design & development, from concept to market release. Your deep understanding of medical device regulations, standards, and quality management systems (QMS) will be essential in collaborating with cross-functional teams to execute and document design controls, risk management, and validation activities. **Key Responsibilities:** - Lead quality engineering activities in product development projects, ensuring compliance with ISO 13485, FDA QSR/QMSR, EU MDR, and other applicable regulations and standards. - Facilitate the application of design controls, including planni...

Greetings from Maneva! Job Description Job Title-Medical device Packaging Specialist Experience-7 - 12 Years Location-Bangalore Notice-Immediate to 15 days Requirements:- Possesses sufficient engineering acumen required to support technical activities such as running engineering tests, performing biocompatibility on packaging, assessing sterilization impacts, and coordinating and generating testing protocols. Knowledge of ISO 11607 part I & part II, EUMDR Regulation (EU) 2017/745, and cGMP's requirements. Working knowledge of packaging equipment for all related processes, ISTA, ISO, and ASTM standards. Experience in sustainability and process improvement initiatives Knowledge of Microsoft Of...

Job Description Job Title: Software Design Quality Engineer Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. You are responsible for Ensure that appropriate project plan and quality plans are made that include all stages ...

The main responsibility of this role is to ensure that all project deliverables meet internal Quality Management System (QMS) standards, defined templates, and Critical to Safety (CTS)/Critical to Quality (CTQ) quality gates before submission. This involves reviewing Design History File (DHF) documents for completeness, consistency, and QMS compliance, as well as performing CTS and CTQ checks across documentation. Additionally, supporting traceability between user needs, product requirements, and verification/validation is essential. Another key aspect of the role is monitoring changes to QMS procedures/templates and managing any resulting documentation updates. Collaboration with Regulatory...

Job Description Job Title: Software Design Quality Engineer Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. You are responsible for Ensure that appropriate project plan and quality plans are made that include all stages ...

Job Title Design Quality Engineer Job Description Job title: Design Quality Engineer - Medical Devices The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your role: Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design. Validate key design inputs like usability, reliability, performance, supportabili...