Quality Systems Specialist I

Position Summary:\ Responsible for ensuring operational adherence and compliance to Cirtec Medicals Quality Management System (QMS) requirements. Ensure compliant execution and coordination of system elements within the Quality Systems & Control functions team.\ Key Responsibilities:\ - Initiate Nonconforming Material Reports (NCMRs).\ - Initiate or Support investigation/analysis of returned/complaint materials.\ - Coordinate or support activities related to NCM, Complaint, RMA, and CAPA processes.\ - Support investigation and root cause analysis of issues.\ - Escalate material nonconformances to CAPA system based on trending and monitoring analysis.\ - Maintain quality system documents related to NCMR, CAPA, and Complaint systems.\ - Initiate or review document changes including quality procedures.\ - Review quality documentation and records and update/approve as required.\ - Consistently abide by and conforms to all established Cirtec Medical policies and procedures.\ - Respond and adapt to changing priorities with minimal disruption.\ - Support CAPA activities, as necessary, driving corrections and corrective actions to successful completion.\ - Provide support to the Supplier Quality management group as needed.\ - Provide support during internal audit and external audits.\ - Ensure adherence to training requirements regarding Quality Management System elements, controls, processes, and procedures.\ - Support Corporate Quality Management System initiatives and continuous improvement activities.\ - Calculate or monitor key quality metrics.\ - Ensure compliance to regulatory standards and requirements as applicable.\ - Ensure compliance of all site personnel to Corporate and site-level QMS and functional training requirements.\ - Must be knowledgeable of, and adhere to, the Cirtec Medical Quality Management System and its requirements.\ - Must be able to successfully meet Cirtec Medical-specific positional/functional on-the-job training requirements as provided.\ - Must follow occupational Safety and Health requirements including Personal Protective Equipment (PPE) guidelines and rules.\ - Adhere to professional workplace attire, time, attendance and leave of absence policies.\ - Complies with company, quality and safety standards, policies, and procedures.\ Must Have:\ - Associates of Science Degree in Manufacturing, Engineering, or Technical Field, or equivalent of directly transferrable industry work experience (Engineering or Quality discipline preferred).\ - Experience examining the data for patterns and trends and working on cross-functional teams.\ - Knowledge of, and experience with, GMP/ISO Standards.\ - Must demonstrate ability and/or experience in computer use and general office software - Microsoft Office (i.e., Outlook, Word, Excel, and PowerPoint).\ - Hands-on self-starter with ability to work both independently and as part of a team.\ - Must be able to read, write and speak fluent English.\ - Ability to work with a wide variety of functional areas, including R&D, Manufacturing, and QA, as required accomplishing results with minimal guidance.\ Good to have:\ - Advanced Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred) preferred.\ - Quality certification(s) (e.g., ASQ CQT, CQI, etc.) preferred.\ - Class I, II and/or III Medical Device manufacturing experience preferred