Software Quality Engineer III job in Temecula, CA
Vacancy has expired
Temecula, CA CorTech LLC
| Job Ref: | 341772 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 68.98/Per Hour |
| Remote: | No |
Location |
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| City: | Temecula, CA |
| Post Code: | 92592 |
| Map: |
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Description |
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CorTech is seeking to hire a Software Quality Engineer III for our client in Temecula, CA! Benefits Available! Weekly Pay! $68.98/Hour Start Time (AM/PM) 9am End Time (AM/PM) 5pm This is a non-exempt position. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout Client. Duties: Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. Create and execute or direct software validation protocols traceable to system/software requirements. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Assist in the completion and maintenance of risk analysis, focused on software related risks. Design and implement various product and process improvement methodologies (i.e, Six Sigma and Lean Manufacturing). Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues. Software scoping and Part 11 audits. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. Qualifications: BS Degree in Engineering or Technical Field or equivalent experience. 2-5 years Software Quality Engineering experience. Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel including internationally. Ability to maintain regular and predictable attendance. POSITION We have an opportunity for a Software Quality Engineer III. You will ensure that computerized software systems used in the support of the Quality System or in automated testing laboratory operations are developed, validated, and maintained in compliance with regulatory and corporate requirements. In addition, you may serve as a member on project teams for software products and applications that provide interfaced or customer facing reporting tools to laboratory customers. This position will be responsible for generation and review of quality system documentation output as they apply to the development, verification, validation, use, and maintenance of applications, software, and or firmware. This position requires coordination of activities with other engineering, operations, and quality functions and departments and will estimate, plan, and review your own and others' work. RESPONSIBILITIES This role supports the development, implementation, improvement, and/or effectiveness of Quality Systems in compliance with applicable company, laboratory, FDA, ISO, and other regulatory agency regulations, policies, and standards through implementation of effective software validation and change control processes. Completes Software Quality Assurance (SWQA) tasks in accordance with current Quality System Requirements. Works independently according to established objectives. Can plan and coordinate own work according to higher-level project schedules. Reviews pre-defined deliverables/activities as identified in Non-Product Software (NPSW) quality processes and/or Product software quality processes/project plans or equivalent project plan. Provides accuracy, clarity, consistency, completeness, and compliance for multiple projects. Deliverables include System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices, and Verification/Validation Summary Reports for assigned projects. Reports unexpected events, issues, or software bugs which occur during verification/validation to project team and management and according to established quality processes. Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Client Corporate requirements as they relate to the development, verification, validation, and maintenance of computerized systems used in the Quality System as well as those used in development of software/firmware products. May develop and maintain Validation Master Plan(s). Minimum Qualifications Bachelor?s degree, or equivalent experience, in a scientific, technical, or engineering discipline. 5+ years? experience in software validation of commercial systems, Enterprise Resource Planning systems (ERP), Manufacturing and Distribution systems and Laboratory Information Management Systems (LIMS). 5 or more years of experience in Software Quality Assurance and/or Software Validation. Knowledge of FDA QSR, relevant ISO and EU guidelines are a must! 5 or more years of project experience in software testing/validation practices, methodologies and techniques, preferably in testing medical devices or pharmaceutical manufacturing systems. Industry experience in validation of software systems according to accepted industry framework such as GAMP5 or ICH guidelines and principals. Preferred Qualifications Experience with Privacy (PII), General Data Protection Regulation (GDPR) and/or Cybersecurity regulations is highly desired. Experience with Privacy (PII), General Data Protection Regulation (GDPR) and/or Cybersecurity regulations is highly desired. Experience performing software vendor qualification assessment and audit is a plus. Strong analytical, written, and verbal communication skills and the ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds. ASTQB or similar certification in software quality assurance or software validation is beneficial. | |
ref: (341772)
1110 days ago
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