02 Sep
|
Quest Global
|
Pune
Job Requirements
At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.
- Key Responsibilities
- B.E. in Mechanical Engineering / MS in engineering preferred / Equivalent Degree
- 4-8 years of experience in Design for Medical Devices / Home Appliances / Personal Health
- Experience of collaborating with multiple stakeholders and generate labeling requirements.
- Experience in translating the labeling requirements into a labeling plan for a given project.
- Collaborate with the regulatory functions to develop labeling for the device, packaging and IFU’s as required.
- Creation and change management of Product Labels, IFUs, Box Carton Artwork and Ancillary Labels.
- Managing and monitoring labeling documents and symbols
- Creation and change management of country-specific localization and distributor labeling.
- Release of Labeling in the PLM System (Windchill, Teamcenter, Agile etc.)
- Support Verification & Validation activities, Quality & Compliance and audits, and quality management labeling systems (CAPAs, NCRs, etc.)
- Lifecycle management and change control in product development setting (preferably experience with Windchill)
- Preferred if possess knowledge and experience on interpreting and translating standards on IEC 60601 (medical electrical equipment) & IEC 6060335 (safety standard household equipment) into medical labelling requirements
- Proven design engineering and project management experience leading cross-functional teams
- Experience supporting gl
📌 Mechanical Design Engineer (Pune)
🏢 Quest Global
📍 Pune