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Engineer, Software Quality

Pleasanton, CA 94588

Posted: 11/01/2024 Employment Type: Contract Job Category: Engineering Job Number: 615546 Is job remote?: No Country: United States

Job Description

This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized.

Duties:
Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and NManufacturing Engineering in the completion of system/software requirements and other verification and validatiton 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.

This is a non-exempt position.

?Pay ranges between $45-50/hr based on expereince 
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About Pleasanton, CA

Ready to embark on a fulfilling career journey in the vibrant region of Pleasanton, California? This picturesque city nestled in Alameda County offers a unique blend of suburban charm and exceptional growth opportunities for job seekers. Known for its charming downtown area with historic buildings, Pleasanton boasts a thriving arts scene with galleries like Firehouse Arts Center and Bankhead Theater. Indulge in the region's diverse cuisine, explore the scenic trails of Shadow Cliffs Regional Recreation Area, and catch a game of the Oakland Athletics at the nearby RingCentral Coliseum. Embrace the enchanting culture and endless possibilities that Pleasanton has to offer as you explore our curated job listings to find your perfect match. Let's kickstart your career journey in Pleasanton, CA today!