Description
Main Responsibilities- Identifies and manages risk throughout the development process through the creation of the risk management file and use of FMECA and/or other risk management tools.
- Contributes to Quality System updates such as risk management SOP updates and ensuring site le
- vel SOP's comply with external standards like ISO 14971.
- Develops master test plans that encompass design verification, design validation and process validation activities.
- Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
- Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
- Assists with the analysis and resolution of design or manufacturing problems as these arise.
- Analyzes and investigates returned clinical investigation products to determine the cause for return.
- Contributes to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other similar products.
- Participates in supplier selection process and component specification reviews to ensure that purchased items meet desired specifications.
- Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices
- Evaluates and dispositions nonconforming materials and products used in design and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements
- Comply with applicable FDA and international regulatory laws/standards and company code of conduct.
Education / Experience Requirements
- Bachelor's Degree in Science or Engineering (or related field).
- 5 - 7 years experience in Quality Engineering in the medical device industry (or related industry).
- Experience in vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and/or guide wires preferred
- Experience in related engineering areas, e.g. Design Quality, R&D, Process Development, New Product Development
- Risk management experience
- ISO Standards
NOT seeking candidates with Operations or Manufacturing Quality experience
To find out more about Real please visit www.realstaffing.com