Read and interpret technical drawings, procedures, and protocols.
Import and maintains the project documentation in online RM tool throughout all phases of NPD and Sustaining.
Investigates and evaluates the compliance requirements driven from organization’s QMS/Work Instructions and validate the same in templates developed in RM tool.
Investigates and evaluates existing RM tools/technologies – JAMA, Polarion, Cockpit etc.
Investigates compliance gaps in project documents and resolve them with project stake holders. Collaborate with cross-functional process, method, and teams to understand and implement solutions to resolve compliance gap issues in documents.
Performs validation of patches and versions of RM tool as and when available.
Support multiple projects across different time zones - Asia, Ireland, and North America
Qualifications Required:
Mechanical Engineering ( B.E./B.Tech) with 4-5 years of experience
Preferred experience in management of DHF documentation during full life cycle of medical device as per ISO 13485, and ISO 14971
Preferred experience in RM tools like JAMA, Polarion, DOORS, Cockpit
Knowledge of MS Office Tools – Word, Excel, PowerPoint.
Strong attention to detail with good communication skills.
Strong strategic / analytical thinking and problem-solving abilities, with a data-driven approach to decision-making.
Ability to collaborate and work as a team player.
Nice to have experience in product lifecycle management software and tools.