Experis, a ManpowerGroup company, has an exciting contract opportunity with one of our key clients, a global biopharmaceutical company that is engaged in the discovery, development and manufacturer of healthcare products. On this team, you will perform a critical role in the team as a highly independent scientist with a strong background in bioanalytical science.
Job Title: Development Quality Engineer II
Location: St. Paul MN 55117
Duration: 12+ Months Contract
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 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.
Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements, assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.
Assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues, apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues, support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements, additional duties may be identified by functional management based on the current project/business objectives.
Years' Experience: 2-5
Skills: Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills
Education: Bachelor level degree in an Engineering Discipline or other technical field experience
