Engineer, Software Quality - Senior or Lead

Job Description





This is a non-exempt position. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division. 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 (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. BS degree in Engineering or Technical Field or equivalent experience. Qualifications: At least 7 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 skills. Advanced Information Technology and data mining skills. Prior medical device 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 travel approximately 5-25%, including internationally. Ability to maintain regular and predictable attendance.





About Kyyba:





Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.





At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development. 





Disclaimer: 





Kyyba is an Equal Opportunity Employer.





Kyyba does not discriminate on the basis of , , , , , , , non-disqualifying physical or mental , , veteran status or any other basis covered by appropriate law. Minorities / / Protected Veterans /Veteran Spouses/ Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”





 





Rewards:





Medical, dental, vision





401k 





Term life





Voluntary life and insurance





Optional Pre-paid legal plan





Optional theft plan





Optional Medical and dependent FSA





Work-visa sponsorship





Opportunity for advancement





Long-term assignment with opportunity for hire by client 





 





SELECT AWARDS





An INC 5000 company for 10 years





Corp! Michigan Economic Bright Spots 





Crain’s Detroit Business Top Staffing Service Companies in Detroit





TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions





Best of MichBusiness winner in HR Wizards & Partnerships





Metro Detroit Elite Category: Recruitment, Selection & for 101 Best & Brightest





101 Best & Brightest Companies to Work for in Michigan