Responsibilities :
- Strong understanding of ISO 13485, MDSAP, EU MDR 2017 / 745, US FDA 21 CFR Part 820 and applicable regulatory requirements .
- Excellent level of knowledge and working experience of Quality domain and its related activities.
- Support in QMS integration of different sites to create a harmonised QMS.
- Support in Quality maintenance activities procedure creation / update, work instruction creation / update for functions like CAPA, complaints, supplier quality, training, internal audit, risk and design remediation, and cybersecurity quality artifact creation.
- a including tasks for input review, providing inputs to the cross-functional team on gaps, leading / participating in review meetings, coordinating with the cross-functional team for closure of assigned tasks of remediation.
- Support on ongoing design projects.
- Support in LMS implementation.
- Support in data migration validation.
- Support in document migration validation.
- Excellent knowledge about regulatory standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366 etc.).
- Handling and resolving technical queries on timely manner.
- Active participation and interactions with clients and other cross-functional teams (CFT's).
- Must have ability to deliver solutions that are customized as per client requirements in terms of technical as well as for commercials.
- Experience of process compliance and developing schedules to meet delivery timelines.
Requirements :
- B.E (Mechanical or Biomedical) with 6 to 8 years of experience in Quality in Medical Devices industry (Experience in SaMD would be preferred).
- Mandatory to have working proficiency with Microsoft Office- Microsoft Excel, PowerPoint, Outlook, Teams, etc.
- High Learning Agility and Good problem-solving skills Able to learn continuously, solve issues quickly and effectively with minimal supervision.
- Highly Customer oriented with an understanding of delivery and fulfilment as per customer demands. Able to work under pressure and meet tight timeline.
- Self-motivated, proactive, has strong organizational skills, and knows how to work collaboratively in a team environment.
- Good verbal and written communication skills in English.
- Strong interpersonal skills and the ability to effectively communicate with a wide range of stakeholders and constituencies in a diverse community and cross geographic culture mostly through virtual mediums such as Emails, Chats and Virtual Meetings.
- Ability to plan, manage, organize and report in an efficient way .
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