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Quality Systems Specialist I Cirtec Medical Corporation Quality Systems Specialist I Lowell, MA Apply 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:

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• 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.

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Must Have:

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• 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:

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• 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 Active Filters Quality Systems Specialist I Lowell, MA Clear All Apply