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Nellcor Puritan Bennett, is now the Respiratory and Monitoring Solutions (RMS) business unit of Covidien, formerly Tyco Healthcare. RMS systems are used to monitor, diagnose and treat respiratory disease and sleep disorders, and they provide life sustaining ventilation and oxygen support for patients.
In addition to Respiratory and Monitoring Solutions, Covidien also manufactures, distributes and services a diverse range of industry-leading product lines, including surgical devices, energy-based devices, pharmaceutical products, imaging solutions, patient care and safety products, and medical supplies.
For more information, visit us as www.covidien.com.
Sr. Quality Assurance Engineer
There are 2 openings for this position, one is located in Boulder, CO and the other is located in Carlsbad, CA.
SUMMARY OF POSITION: Integral member of the team representing quality engineering in design and development of medical device products, primarily ventilators and ventilation accessories, and facilitate the application of design controls. Translate Quality Standards into processes and procedures, and apply these to the new product design process.
ESSENTIAL FUNCTIONS: 1. Assist R&D in the development of and/or review proposed new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product requirements. 2. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation by providing leadership to the team with respect to regulatory requirements of new product development and/or product changes. 3. Be highly engaged to ensure successful transfer of new products to production facility. Review production processes for quality of validation through IQ, OQ, and PQ activities. 4. Assist in the development of design and process verification and validation test plans. Ensure verification / validation results demonstrate compliance to medical device standards. Represent Quality Engineering in the approval of protocols and reports, ensuring defendable practices and conclusions. 5. Provide training to project teams on verification/validation, statistical methods and design controls. 6. Accountable for product risk assessment efforts within product teams. 7. Participate in and/or review all team deliverables for Design History Files and Technical Files for conformance to applicable requirements. 8. Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues. 9. Conduct internal quality system and supplier quality audits.
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