Quality Document Technician

About the role

As a Quality Control Document Technician at Cirtec Medical, you will ensure that the final product complies with the customer’s requirements and specifications by performing DHR Creation and Review as well as Lot Release.

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.
• Work alongside Quality Engineers and Production Supervisors to effectively document MRB activity.
• Cross-train in various QC operations, including clean room monitoring, Incoming QC, Outgoing QC, and In-Process QC.
• Work independently with minimal supervision.
• Coordinate with Packaging Department team members to ensure shipping deadlines are met.
• Demonstrate professional conduct with coworkers and managers.
• Meet Cirtec standards for quality and productivity.
• Complete required paperwork and documentation error-free while following Good Documentation Practices.
• Follow all procedures for cleanroom operation, cleanroom attire, and contamination control.
• Adhere to all Cirtec procedures for traceability, line clearance, process control, safety, and housekeeping.
• Maintain related Document Control files.
• Accurately input data into ERP system daily (including clock-in time, work orders, operations, indirect work, quantities produced, and deviated parts).

Requirements

• High school diploma or equivalent.
• 2+ years of Quality Assurance experience in a manufacturing facility.
• Working experience with measuring systems (optical comparators, vision systems).
• 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.
• Excellent organization and time management skills with an ability to think proactively and prioritize work.
• Flexible and able to accommodate changing priorities and directions.

Preferred Qualifications

• Certifications and experience in the silicone/rubber industry.
• Knowledge of document control procedures with data storage, maintenance, revision, and archival background.
• Familiarity with FDA Quality System Regulation (QSR) and ISO 13485.
• Ability to work with a wide variety of functional areas including Program Management, R&D, Manufacturing, and QA.

Pay

$22.70 - $34.04 per hour.

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.