Are you a High Quality, Quality Assuring Professional? Do you hold the awesomeness of working on New Products? Does your quality check gets better rating than Martin Scorsese's classics?
If yes, then this is your platform to show your talent.
We(Our Client) are a Fortune 500 Medical Devices company. We are in market since early 40's. Spread across the globe in more than 80 Countries, we specialize in providing products like surgical devices, medical Instruments & supplies, etc. We are looking for a Quality Engineer of New Products in Florida.
Check out the details & let us know if you can act on the given script.
Your area of action in this position will be..
- Extensively focusing on new product/software development.
- Developing Quality Assurance Plans for new products.
- Developing Risk Management plans & reports.
- Ensuring software development standards are met.
- Participating in design reviews and tracking the mitigation of those issues throughout the development process.
- Managing the hazard and risk analysis processes.
- Partnering with engineering team to define design verification and validation test requirements and promote efficient testing practices.
- Supporting in completion of final design verification and design validation test reports and graphical support when necessary.
- Defining and reviewing sterilization, biocompatibility, and packaging requirements for the devices to ensure compliance to applicable standards.
- Utilizing standard statistical analysis and problem solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
- Identifying supplier assessment requirements and communicating these to the supplier quality group.
- Supporting quality system maintenance primarily for the design control process.
- Driving CAPA teams in the analysis and resolution of product quality issues.
- Creating quality assurance documentation to support regulatory submissions.
- Evaluating product design changes for verification and validation requirements and assist in change implementation.