Local to Rochester NY_Medical Device Validation engineer

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement.

Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. 

Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one’s business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel’s through us.

We make sure that we deliver performance driven products that are optimally developed as per your organization’s needs. Take a shot at us for your IT requirements and experience a radical change.

We are looking to fill a mid level Medical Devices Validation engineer role in Rochester NY.

• A minimum of a BA/BS in Life Sciences, Engineering, Physical Science or a related discipline is required; an MA/MS in Life Sciences, Engineering, or Physical Science is preferred.
• Must have at least 5 years of related experience in Medical Device quality system management, including experience in working under Design Control.
• ASQ certification a plus.
• Computer skills/data analysis skills (Word, Excel, PowerPoint, Minitab, Visio, MS Project) is required.
• Effective oral & written communication skills are required.
• Works independently and sets an example in ensuring compliance to Design Controls and other Quality System requirements to assigned project(s).
• Utilizes Six Sigma/Process Excellence to solve complex problems and develop optimal product performance.
• Partners with R&D, Operations, Quality, Regulatory and Compliance, suppliers and other groups to ensure effective product development and transfer of knowledge.
• Provides technical input as appropriate.
• Ensures effective implementation of risk management requirements to prevent unanticipated failure modes and quality issues.
• Provides input as needed to regulatory inspections.
• Executes Failure Investigations and corrections of design related quality issues.
• Utilizes advanced Quality Engineering tools (data analysis, statistics, sampling plans, etc.) to ensure effective product development.
• Participates in post-product launch failure investigations.
• Provides guidance and leadership to junior members of the team..
• Suppliers/External Manufacturers: Directly or indirectly support design change control activities.
• Review and approve plans/protocols and reports, deviations/nonconformances, and document changes through the change control processes for accuracy and completeness.
• Proactively identifies issues, troubleshoots issues, and escalates concerns as appropriate. Adheres to strict procedural and quality standards including thorough and accurate documentation, testing protocols

Webcam Interviews are acceptable for this position.