Quality Systems Specialist I

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary: 

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.

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 

Salary Range:$70,000 to 80,000 based on skills and experience

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.