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Apple
San Diego, CA, United States
Summary Posted: May 30, 2024Weekly Hours: 40Role Number: 200549461Would you like to build and seamlessly integrate technologies that enrich people’s lives and deliver the best user experience? We are the Product System Quality team, and we're looking for an experienced and highly motivated Software Quality Assurance Engineer. You will join a dedic
Job Source: AppleSAIC
San Diego, CA, United States
Description SAIC is the premier Joint All Domain Command and Control (JADC2) integrator with expertise in transforming legacy command and control systems into a modern hybrid cloud environment to accelerate decision making and increase mission success. This new program is part of a broader effort to provide a tactical operational picture aligned w
Job Source: SAICPublicis Groupe
San Diego, CA, United States
Company Description Job Description Responsibilities Design and develop automated unit and regression test scripts within our current framework and infrastructure using Azure DevOps tools, Selenium with JUnit and Cucumber, JDBC, etc. Employ specs/use cases/business rules to develop test cases and scripts Prepare and document test plans, test c
Job Source: Publicis GroupeApple
San Diego, CA, United States
Summary Posted: May 30, 2024 Weekly Hours: 40 Role Number: 200549461 Would you like to build and seamlessly integrate technologies that enrich people’s lives and deliver the best user experience? We are the Product System Quality team, and we're looking for an experienced and highly motivated Software Quality Assurance Engineer. You will join a de
Job Source: AppleKyocera International
San Diego, CA, United States
Description Company Overview With nearly 80,000 employees globally, Kyocera is a leading manufacturer of high-tech Ceramics which are used in a variety of industries including aerospace, automotive, medical applications, and semiconductor processing. You will find our innovative materials in everything from smartphones to space shuttles! Check ou
Job Source: Kyocera InternationalEpsilon
La Mesa, CA, United States
Job Description Responsibilities Design and develop automated unit and regression test scripts within our current framework and infrastructure using Azure DevOps tools, Selenium with JUnit and Cucumber, JDBC, etc. Employ specs/use cases/business rules to develop test cases and scripts Prepare and document test plans, test cases, and testing strat
Job Source: EpsilonEpsilon
Santee, CA, United States
Job Description Responsibilities Design and develop automated unit and regression test scripts within our current framework and infrastructure using Azure DevOps tools, Selenium with JUnit and Cucumber, JDBC, etc. Employ specs/use cases/business rules to develop test cases and scripts Prepare and document test plans, test cases, and testing strat
Job Source: EpsilonEpsilon
Poway, CA, United States
Job Description Responsibilities Design and develop automated unit and regression test scripts within our current framework and infrastructure using Azure DevOps tools, Selenium with JUnit and Cucumber, JDBC, etc. Employ specs/use cases/business rules to develop test cases and scripts Prepare and document test plans, test cases, and testing strat
Job Source: EpsilonSan Diego, CA, United States
Summary of Essential Duties and Responsibilities
Provides technical engineering support to new and existing product development and sustaining engineering teams. Applies knowledge of test method principles and quality engineering techniques to development efforts as a member of one or more cross-functional development team(s). Ensures products are tested in accordance with applicable industry standards, regulatory requirements, and customer requirements.
Provides regulatory support for current product operations and manufacturing.
Education and/or Experience
At minimum, bachelor's degree in technical discipline, preferably engineering or science. MS desirable.
A minimum of 4 plus years' experience in Medical Device or Pharmaceutical Quality Engineering or a master's degree in a scientific discipline with at least 2 years' experience in Medical Device or Pharmaceutical Quality Assurance/Engineering.
Proven record of providing Quality Assurance input to compliance of regulated products.
Demonstrated ability to work at all stages of product development.
Thorough understanding of the CFR, FDA/ICH guidelines and cGMP's as they pertain to Medical Devices and combination products
Demonstrated ability to work independently and produce professional work products.
Strong written and verbal communication skills
Experience participating on project teams.
Experience implementing an eQMS is highly desired.
Experience in related areas, including R&D or manufacturing, may also be applicable if experience includes work responsibilities listed above.
Strong work ethic and demonstrated ability to deliver assignments on time.
Experience working with Drug/Device Combination devices is highly desired.
Experience working with and/or validating analytical equipment for polymer manufacturing, such as HPLC, GPC, and GCMS is highly desired.
Required Knowledge/Skills
Knowledge of global cosmetic and cosmetic/device product regulations including The Food Drug and Cosmetic Act (FD&C), Good Manufacturing Practices (GMP's), EUMDR, and ISO13485.
Quality system regulations, Device classification, medical device submission and registration requirements, labeling and advertising requirements and restrictions, MDR reporting, recall procedures, and FDA and International regulations related to assigned duties.
Thorough familiarity and ability to work with office automation programs and corporate database tools.
Communicates effectively, both orally and in writing. Demonstrates excellent interpersonal skills with personnel at all levels and exhibits a high degree of initiative and motivation.
Physical Demands/Working Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit or stand for prolonged periods of time, frequently in front of a computer.
Must be able to travel occasionally.
Email Alert for Quality Assurance Engineer jobs in San Diego, CA, United States
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