Systems Evaluation EngineerApex Systems is currently seeking a Systems Evaluation Engineer for one of our top Medical Device clients in Arden Hills, MN.Location: Arden Hills, MN - hybridOrganization: Fortune 500 Medical Device company who prides themselves on culture, work-life balance, and overall well-being (winner of Forbes Best Employers for Diversity (2018 – 2020), Forbes World's Best Employers (2018, 2020) and Forbes Best Employers for Women (2018))Job PurposeDevelops, establishes and maintains quality engineering methodologies, systems, and practices which meet customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.Functional Engineering Roles include: Design Assurance, Operations Quality, Software Engineering, Supplier Assurance, Product Analysis, Metrology, Microbiologist, Chemist.Key Responsibilities1.
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.2. Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.3. Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.4.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.5. Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.Quality Systems Duties and Responsibilities:Build Quality into all aspects of their work by maintaining compliance to all quality requirements.