Software Engineer Quality - FB2025 in Pleasanton

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Job DescriptionJob Description

Description:

This is a non-exempt position. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering and Risk assessment support for software utilized throughout the division.

Duties:
- Work with Design and Test Engineering in the completion of system/software requirements and other verification and validation processes.
- Review software validation protocols traceable to system/software requirements.
- Participate in meetings and provide guidance on Software Event/Defect or anomalies.
- responsible for driving the completion and maintenance of risk analysis, focused on software related risks.
- Design and implement various product and process improvement methodologies (ie 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.
- At least 5 years Quality Engineering experience.
- Detailed knowledge of FDA QSR, IEC 62304, and ISO 13485.
- Advanced computer skills, including data analysis and report writing skills.
- Prior medical device or IVD experience .
- ASQ CSQE certification desired.
- Experience working in a broader enterprise/cross-division business unit model .
- 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 maintain regular and predictable attendance.

Looking for someone well versed in software verification and validation and risk controls/activities and trace matrix.

Company DescriptionOverview

TechLink Systems is a provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.

We also have recruitingCompany DescriptionOverview\r\n\r\nTechLink Systems is a provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\n\r\nWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness. \r\n\r\nWe also have recruiting

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