Hi,
Hope you are doing great!
We have an urgent below "software quality engineer" position with one of our client 6+months contract Carlsbad ,CA, if you are interested please share your updated resume along with contact details to chandra_madu@aesinc.us.com
Job Title :software quality engineer
Location :Carlsbad ,CA
Duration:6+months
Job description:
1.Provide quality software engineering support in design and development of medical device products, specifically ventilation products. Facilitate the application of software design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and/or safety issues.
2.5-10 years of quality engineering experience or equivalence.
3.Strong familiarity with regulatory requirements (e.g. ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820, ISO 14971, ISO 62304).
4.Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 a distinct advantage.
5.Experience in risk evaluation techniques, e.g. HHE, Product Risk Assessment, SFMEA, DFMEA, PFMEA & fault tree analysis.
6.ASQ CQE, CRE, CSQE certification desirable, but not essential. Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
7.Participate in Software development reviews, code reviews and formal software technical reviews .Provide training to project teams on procedures, verification, validation, statistical methods and design controls.
8.Review new and modified product designs for quality characteristics, reliability, serviceability, testability and traceable to product requirements.
9.Ensure successful transfer of new products to production facility. Review production processes for quality of validation.
Thanks & Regards,
Chandra Madu
Agile Enterprise Solutions Inc.
PH: 972-427-1725
E: chandra_madu@aesinc.us.com|| www.aesinc.us.com
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