Development Quality Engineer II

Spectraforce Technologies
United States, Minnesota, St. Paul
Dec 18, 2024
Title: Development Quality Engineer II Duration: 05+ Months Location: St. Paul, MN 55117 Key skills: NCMRS CAPA'S Any process Validation Experience Operations Quality Design Development Quality Verbal and written communication Interpersonal, teamwork, individual contributor Multitask, strong organizational experience Advanced computer skills Education Requirements: Bachelor-level degree in an Engineering Discipline or other technical field Job Duties: Participate in or lead teams in supporting quality disciplines, decisions, and practices Lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects accountable for the generation of PDP design verification test plans/reports for product/system requirements lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments lead identification of essential outputs and generate Essential Output reports accountable for the completion of labeling verification activities and labeling verification reports work with design engineering in the completion of customer/system/product requirements work with design engineering in the completion of product verification and validation endure DHF content completion, integrity, and regulatory & standards compliance collaborative communication resolving gaps, and completing document change request reviews in a timely and objective manner identify and implement effective process control systems to support the development Note: Seeking a candidate that has 1-4 yrs of work experience. 4+ years of experience will be considered as overqualified. Candidates that have worked in the Medical Device Field Experience is a plus.