Quality Documentation Retention Specialist - (NovelCath)

This is a first shift role.

About us:

NovelCath a Cirtec company specializes in the design and development of complex, minimally invasive, interventional medical technologies. We have delivered first-of-a-kind medical devices for the Interventional Cardiology, Structural Heart, Electrophysiology and Neuromodulation markets.

For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.

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 challenge, you may be a perfect fit for our team!

Position Summary:

The position will be responsible for ensuring operational adherence and compliance to Cirtec Medical's Quality Management System (QMS) Record Retention requirements. This may include Record Control Systems, maintaining paper training records, Shipping documentation support, Internal & External Auditing documentation support, and training and education support.

Key Responsibilities:

• Review Production travelers for accuracy - ensure all fields are completed, data is accurate, and any mistakes correctly amended
• Create inspection shipping documentation packets and complete required database entry
• Review material specifications on customer print against material used during manufacturing, ensuring all chemical compositions and ASTMs are met
• Create "Certificate of Compliance" for each shipment, history cards, raw data sheets for customers, as required
• Support internal and external audits with documentation, when applicable
• File organization and maintenance, per quality metrics and requirements

Must Have:

• High School or GED
• Minimum of 1 year of experience in a professional workplace environment
• Ability to read, write and comprehend English
• Proficient in computer and use of Microsoft Office (Outlook, Word, Excel, etc.)

Good to have:

• Class I, II, or III Medical Device manufacturing experience
• Experience with GMP/ISO Standards

Salary Range: $22.00 to $24.00/hour, based on experience

Shift Hours: M-F, 6:00AM to 2:30PM

Cirtec Medical Corporation considers everyone 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 its related companies fully endorse equal opportunity. 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 an enjoyable 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 stage of your career and life. 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.