Quality Document Technician

Cirtec Medical; Sturtevant (WI); On-site; USD 30,000 - 47,000; Full time

Job summary

Cirtec Medical in Wisconsin is seeking a qualified Quality Control Document Technician to ensure final products meet customer specs through DHR creation/review and lot release.

You will support QA engineers and production supervisors, maintain documentation, input data into ERP, and uphold cleanroom and quality procedures while prioritizing accuracy and traceability.

Qualifications

• High school diploma or equivalent is required.
• At least 2+ years of Quality Assurance experience in manufacturing.
• Experience with measuring systems (optical comparators and vision systems) is required.
• Proficient in Microsoft Office and email communication.
• Strong organizational skills and the ability to work with minimal supervision.

Responsibilities

• Interpret and comply with Cirtec’s quality assurance standards.
• Perform daily DHR Review/Creation on all production work orders.
• Perform daily Lot Release on all shipments.
• Maintain Hold Cage Logs and non-conformance tracking.
• Collaborate with Quality Engineers and Supervisors on MRB activity.
• Crosstrain in QC operations including clean room monitoring and various QC stages.
• Input data into ERP daily with accuracy and timeliness.

Skills

Quality Assurance experience

Detail-oriented

Teamwork

Strong organizational skills

Education

High school diploma or equivalent

Tools

Measurement systems

Optical comparators

Vision systems

Microsoft Office (Word, Excel, Email)

Job description

About us:

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.

Description

About us:

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 Quality Control Document Technician ensures that the final product complies with the customer’s requirements and specifications by performing DHR Creation and Review as well as Lot Release.

Key Responsibilities

• Interpret and comply with Cirtec’s quality assurance standards.
• Perform daily Device History Record (DHR) Review/Creation on all production work orders.
• Perform daily Lot Release on all shipments.
• Maintain Hold Cage Logs.
• Carefully maintain non-conformance tracking including tracking ID issuance, closure dates and verification against DHR release within Feedback Log.
• Ability to work alongside Quality Engineers and Production Supervisors and Leads to effectively document MRB activity.
• Crosstrain in various QC operations, including clean room monitoring, Incoming QC, Outgoing QC, and In-Process QC.
• Must be able to work independently with minimal supervision.
• Conversant with current Cirtec NPI/CAPA/Validation procedures.
• Coordinate with Packaging Department team members to ensure shipping deadlines are met.
• Cooperate with and demonstrate professional conduct with coworkers and managers.
• Meet Cirtec standards for quality and productivity.
• Complete various required paperwork and documentation error free while following Good Documentation Practices.
• Follow all procedures for cleanroom operation, cleanroom attire, and contamination control.
• Follow all Cirtec procedures for traceability, line clearance, process control, safety, and housekeeping.
• Responsible for maintaining related Document Control files.
• Accurately input data into ERP system daily (including clock in time, work orders worked on, operation worked on, indirect work performed, quantities of parts produced and quantities of parts that are deviated)

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Must Have

• High school diploma or equivalent.
• 2+ years of Quality Assurance experience in a manufacturing facility
• Working experience with measuring systems (optical comparators, vision systems) required
• Computer proficiency in Microsoft Office (Word, Excel) and email
• Efficient work habits and detail-oriented organizational skills
• Strong teamwork skills with the ability to work with minimal supervision.
• Certifications and experiences in silicone/rubber industry are a plus.
• Ability to work with a wide variety of functional areas including but not limited to Program Management, R&D, Manufacturing and QA as required.
• Excellent organization and time management skills with an ability to think proactively and prioritize work.
• Flexible and able to accommodate changing priorities and directions.

Good To Have

• Knowledge of document control procedures with data storage, maintenance, revision, and archival background.
• Familiarity with FDA Quality System Regulation (QSR) and ISO 13485.

Salary Range: $22.70 - $34.04 / hour

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.

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.