Senior Associate - Quality Assurance Job in Indegene

You will be responsible for: Apply knowledge of design control principles and quality engineering techniques to identify risks in design history file documentation & its management Collaborate with product design/development engineering, regulatory, clinical, marketing, and other organizational partners to assure appropriate quality requirements are defined and conveyed across cross functional teams Support DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained Ensure FMEA s are performed as required to mitigate risks in design, transfer, and manufacturing Support development, implementation and maintenance of Design Verification & Validation (V&V) methodologies and best practices Lead cross functional teams to implement risk assessment and risk management processes Provide documentation to support regulatory submission activities and review content for compliance to applicable regulations Participate in cross functional teams to review and evaluate impact of proposed supplier changes Serve as Subject Matter Expert for regulatory inspections related to Design Controls, Process Validation, Device Master Records and Design History Files Sound knowledge on DHF, DHR, DMR functioning structuring and remediation. Ensures that appropriate Quality plans are made that include all stages of the project life cycle and supports Quality Plan design. Validates key design inputs like: usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs. Provides effective oversight of: the execution of the Quality Plan and any Risk Management activities, and of all design related activities during the overall design and project lifecycle. Act as SPOC responsible to ensure that design quality-related requirements/criteria are completed and meet defined Quality standards. Compilation of documentation for notified bodies, FDA, competent authorities. Analysing and reviewing Test results and preparation of compliance reports. Eye for continuous improvements. Should have knowledge on CAPA process and to support CAPA as facilitator. Conduct training for new resources and helping them to bring up to speed. Should have sound knowledge on Verification and Validation process/activities and methodologies to support the design engineers as needed. About you: Knowledge of relevant external standards for Quality Management Systems for non-medical and medical devices (e.g. ISO 9001 ISO13485, ISO 14971, 21 CFR Parts 803, 806, and 820) Knowledge of SW/HW or combination medical device processes and procedures. Experience in using problem solving tools Experience in working with legal documents Knowledge of external regulations and standards relevant to the relevant products Good knowledge of Engineering process and product life cycle in general and testing process in particular. Needs to be proactive and result oriented, with good verbal and written communication skills Should be flexible and adaptive to work on assignment on different time zones if required. Background /Experience with global medical device regulations, requirements and standards such as ISO13485, ISO9001, MDD, European Medical Device Regulation (MDR), FDA QSR is mandatory. Ability to drive decision-making while effectively communicating detailed information and strategic decisions to project team members of all levels. Must possess a strong customer focus with doing things right the first-time approach and be able to demonstrate high performance behavior of shared accountability.