Senior Specialist at Stryker
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Stryker - Staff Engineer - Product Quality (7-11 yrs)
- Lead Quality Engineering activities in the development of products to ensure the highest level of product and process quality. Partner with Product Development teams to ensure best in class product design.
Support design and development of medical devices as follows :
- Actively participate on teams to support product development activities.
- Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
- Lead risk management activities for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
- Develop insights related to customer needs, product risks, and product performance requirements.
- Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
- Partner with R&D to drive safety and performance in new products
- Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.
- Ensure effective implementation and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.
- Knowledge of New Product Development process
Drawing review : Sound Knowledge of Drawing interpretation and basics of GD&T
Risk management : Sound Knowledge of FMEA (Process & Design)/Control Plans
- Validation support for product, processes, packaging, sterilization
- Design/Process Verification and validations and Design Transfer
- Development/review of Process flow and inspection plans
- Actively participate in design & process reviews to provide Quality input
Minimum Qualifications :
- Graduate Mechanical Engineer
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