Position - Quality Specialist
Location - Two Penn Center,
Philadelphia, Pennsylvania – 19102
Position Summary:
The Quality specialist is primarily responsible for ensuring QMS compliance with respect to ISO 13485, MDSAP, EU MDR 2017/745, US FDA 21 CFR Part 820 and applicable regulatory requirements. The Quality specialist supports TATA ELXSI’s Quality Domain to strengthen customer satisfaction and develop team bonding by team mentoring and also actively engage with cross functional teams and clients to develop new domain capabilities.
Skills and Qualification:
• 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
Role and 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
• Remediation support for Design (DHF), Design content, Risk files, and Cybersecurity, 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.
Have a Great Day !!!
Regards,
Mandy
EMAIL:
Phone : +1 201 855 5604
TextNow : +1 732 398 5499