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
Create Standard Operating Procedures (SOPs) and Work Instructions (WIs) for the printing and application processes of labels.
Creation and change management of country-specific localization and distributor labeling.
Release of Labeling in the PLM System (Windchill, Teamcenter, Agile etc.)
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Support Verification & Validation activities, Quality & Compliance and audits, and quality management labeling systems (CAPAs, NCRs, etc.)
Lifecycle management and change control in product development environment (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 global projects.
Demonstrated strong analytical and problem solving skills.
Working knowledge of Microsoft Project, Excel, Power Point, and Word required
Strong English written and verbal communication skills required.
Proficient with Solid Works, Creo, Microsoft Office suite software
Knowledge of Parametric Modeling, GD&T, Tolerance Analysis, Solid Works experience preferred.
Knowledge of Six Sigma DFSS Techniques
Demonstrated experience with the design and qualification of injection-molded parts
Experience with DFX
Knowledge of Mathcad, LabView, or other Modeling Tools and experience
Knowledge of DFMEA, PFMEA and other Risk Management Tools
Knowledge of DOE, statistical analysis, and Minitab experience is preferred.
Good Hands-on experience in the Windchill PDLM tool
Identify the suitable material and create an EBOM.
Knowledge of ISO13485 is preferred.
Disciplined team worker, ability to work independently.
Ability to present ideas and convince project team members.
Be structured and self-organized.
Excellent communication skills & project management skills
Quality mindset in design and documentation
Good documentation, Communication skill
Familiar to Factory Environment & good RCA skill
Work with different cross functional team such SQA, SCM, Manufacturing Engineer, Operations
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We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.
We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.
Work Experience
B.E. in Mechanical Engineering / MS in engineering preferred / Equivalent Degree
4-8 or more years of experience in Design of labelling 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.
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