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Engineer, Software Quality

Irving, TX 75038

Posted: 05/24/2023 Employment Type: Contract Job Category: Engineering Job Number: 559913-1 Is job remote?: No Country: United States

Job Description

SUMMARY: 
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 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.

Target pay: 29-31/hr

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Irving, TX

Discover exciting job opportunities in the vibrant city of Irving, Texas! Known for its diverse community and thriving economy, Irving offers endless possibilities for career growth and development. With its close proximity to Dallas Fort Worth International Airport, major corporations, and charming neighborhoods like Las Colinas, Irving is the perfect place to advance your career. Explore job listings in this bustling city and be part of the dynamic energy that surrounds attractions like the Toyota Music Factory, the Irving Arts Center, and the Mustangs of Las Colinas sculpture. Embrace the blend of Texan hospitality and cosmopolitan flair that makes Irving a truly exceptional place to work and live. Take the next step in your career journey and find your perfect match in Irving, Texas!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.