Quality Systems Specialist I

About the role

Responsible for ensuring operational adherence and compliance to Cirtec Medical’s Quality Management System (QMS) requirements. Ensure compliant execution and coordination of system elements within the Quality Systems & Control functions team.

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 conform 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.
• Comply with company, quality and safety standards, policies, and procedures.

Requirements

• 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.

Preferred Qualifications

• Advanced Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred).
• Quality certification(s) (e.g., ASQ CQT, CQI, etc.).
• Class I, II and/or III Medical Device manufacturing experience.

Pay

$70,000 to $80,000 based on skills and experience.

Benefits

• Training and career development.
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs.
• Paid Time Off.
• 401(k) retirement savings with a company match.