Software Quality Engineer

Spectraforce Technologies
$30/hr
sick time, 401(k)
United States, Texas, Irving
1901 North MacArthur Boulevard (Show on map)
Oct 16, 2024
Title: Software Quality Engineer Duration: 24 months/W2 Location: Irving, TX 75038 or Lake County, IL 60064 Pay Range starts from: $30/hr on W2 Job Description: Medical device/IVD FDA design control, and software development lifecycle experience is required. 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 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. About Us Established in 2004, SPECTRA FORCE is one of the largest and fastest-growing diversity-owned staffing firms in the US. SPECTRA FORCE is built on the concept of "human connection," defined by our branding tagline NEWJOBPHORIA, which is the excitement of bringing joy and freedom to the work lifestyle so our people (and clients) can reach their highest potential. Our entire workflow cultivates NEWJOBPHORIA with candidates and employees throughout their engagement with SPECTRA FORCE. http://www.spectraforce.com We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 130 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. Benefits: SPECTRA FORCE offers ACA compliant health benefits as well as dental, vision, accident, and hospital indemnity insurances. Additional benefits SPECTRA FORCE offers to the eligible employees include commuter benefits, 401K plan with matching and a referral bonus program. SPECTRA FORCE offers unpaid leave as well as paid sick leave when required by law. Equal Opportunity Employer: SPECTRA FORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation