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Software Quality Engineer - 5967

Company: (IQS) Intelligent Quality Solutions, Inc.
Location: Saint Paul
Posted on: February 23, 2021

Job Description:

This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the company. 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.
Requirements 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.
About IQS
Intelligent Quality Solutions, Inc. (IQS), a division of Maslow Media Group, Inc. operating under the parent company of Reliability Incorporated, is a premier workforce solutions industry leader with a vast portfolio of information technology and engineering workforce management solutions that deliver top talent to our clients enabling them to deliver quality services to their customers. IQS's industry expertise includes Biotech, Medical Device, Healthcare, Energy, IT and Accounting and Finance.
Why Work With IQS
As part of the IQS team, you will be part of an organization that provides rewarding opportunities in some to the most leading-edge industries operating today. Our opportunities challenge and inspire our teams to achieve success as well as provide exceptional career growth and experience. We offer eligible employees a variety of benefits including Medical/Dental Coverage, Competitive Paid Time Off/Holidays, Competitive Salaries and a 401K Plan.

Keywords: (IQS) Intelligent Quality Solutions, Inc., St. Paul , Software Quality Engineer - 5967, IT / Software / Systems , Saint Paul, Minnesota

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